Whey Pro Complete by SP Standard Process

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Serving Size 2 Heaping Tablespoon(s) (2 heaping tablespoons (scoops))

Ingredients	Amount Per Serving
Calories	80 Calorie(s)
Total Fat	0.5 Gram(s)
Cholesterol	25 mg
Total Carbohydrates	2 Gram(s)
Total Sugars	1 Gram(s)
Protein	15 Gram(s)
Calcium (Ca)	40 mg
Sodium (Na)	40 mg
Proprietary Blend	20 Gram(s)
nondenatured Whey Protein concentrate (Milk)
nondenatured Whey Protein isolate (Milk)
Colostrum (Bovine)
Inulin (Chicory root Fiber)
Lecithin (Soy)

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Effectiveness view details

Below is general information about the effectiveness of the known ingredients contained in the product Whey Pro Complete. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BOVINE COLOSTRUM (Colostrum)

POSSIBLY EFFECTIVE

Diarrhea. Oral hyperimmune bovine colostrum seems to help prevent infectious diarrhea and reduces the duration of infectious diarrhea in children. Details: An open-label study in children aged 1-6 years with a history of recurrent diarrhea shows that taking hyperimmune bovine colostrum daily for 4 weeks decreases the number of infectious diarrhea episodes during a 6-month period by around 2 episodes when compared to baseline (95924). Clinical research in infants also shows that drinking formula containing hyperimmune bovine colostrum for 1 week decreases the frequency of infectious diarrhea at 6 months by 1.5 episodes when compared to baseline (101801). Taking bovine colostrum might also reduce the duration of infectious diarrhea related to Escherichia coli. Two small clinical studies in children aged 1 month to 18 years show that bovine colostrum reduces the duration of diarrhea caused by enterotoxigenic E. coli when compared with placebo (2067,101796). The studies used hyperimmune colostrum, which provides high antibody titers against organisms for which the cow has been immunized (4905). Doses studied include hyperimmune bovine colostrum 7 grams three times daily for 14 days in children aged 1 month to 18 years (2067); a specific hyperimmune bovine colostrum product (ImmuGuard, NMI) 3 grams daily if less than 2 years of age, or 3 grams twice daily if over 2 years of age, for 1-4 weeks (95924,101796); and infant formula containing hyperimmune bovine colostrum 0.5 grams/kg for one week (101801).
Exercise-induced respiratory infections. Small clinical studies suggest that oral bovine colostrum reduces the risk of exercise-induced respiratory infection in healthy adults. Details: While results from individual clinical studies are mixed (92413,92416), a meta-analysis of 5 small clinical trials in healthy adults shows that taking bovine colostrum 10 or 20 grams daily for 8-12 weeks during exercise training reduces the rate of upper respiratory symptom days by 44% and the rate of episodes of upper respiratory symptoms by 38% when compared with placebo (92417).
HIV/AIDS-related diarrhea. Small clinical studies suggest that oral bovine colostrum reduces the frequency of diarrhea in patients with HIV/AIDS-related diarrhea. Details: Several very small clinical trials in patients with HIV/AIDS-related diarrhea show that taking bovine colostrum daily for up to 3 weeks seems to reduce the frequency of diarrhea when compared to baseline (4905,4906,4907,4908,92415). The validity of these findings is limited by lack of control group. Hyperimmune bovine colostrum had FDA orphan status for HIV-related diarrhea (9840); however, it has not been FDA-approved for this indication. Most clinical trials have used colostrum from pregnant cows that have been immunized against specific pathogens. The hyperimmune colostrum provides high antibody titers against organisms for which the cow has been immunized (4905). Specific hyperimmune colostrum products showing benefit include ColoPlus by ColoPlus AB and Lactobin by Biotest AG (4907,92415).
Rotaviral diarrhea. Small clinical studies suggest that oral hyperimmune bovine colostrum is effective for treating rotaviral diarrhea in infants and children. Details: Several small clinical studies in infants and children with rotaviral diarrhea show that taking hyperimmune bovine colostrum decreases stool frequency and volume and speeds up the clearance of rotavirus when compared with placebo or baseline (4903,4904,4909,36999,37022,101796). Most clinical trials have used colostrum from pregnant cows that have been immunized against specific pathogens. This hyperimmune colostrum provides high antibody titers against organisms for which the cow has been immunized (4905). Doses studied include hyperimmune bovine colostrum powder 10 grams daily in divided doses for 4 days, hyperimmune bovine colostrum 100 mL three times daily for 3 days, and hyperimmune bovine colostrum 20 mL daily for 2 weeks in infants and children up to 30 months old (4903,4904,4909,36999). A specific hyperimmune bovine colostrum product (ImmuGuard, NMI) 3 grams daily if less than 2 years of age, or 3 grams twice daily if over 2 years of age, for 1 week has also been used (101796).

POSSIBLY INEFFECTIVE

Necrotizing enterocolitis (NEC). Small clinical studies suggest that oral bovine colostrum does not prevent NEC in preterm or very low birth weight infants. Details: A small clinical study in very low birth weight infants shows that giving bovine colostrum (Pedimmune, Merk India Ltd.) 1.2 or 2 grams enterally four times daily until discharge or death does not reduce the risk of NEC when compared with placebo (92411). Another small clinical study in formula-fed, preterm neonates also shows that giving bovine colostrum (Immuguard, Dulex-Lab) for 2 weeks has no effect on the incidence of NEC when compared with a control group (105755). An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not reduce the risk of NEC when compared with a conventional milk fortifier (111140). Additionally, a large clinical study in very preterm infants shows that adding bovine colostrum to breastmilk feeding during the first 14 days of life does not reduce the risk of NEC or shorten the time to full enteral feeding when compared with preterm formula added to breastmilk (114816).
Sepsis. Small clinical studies suggest that oral bovine colostrum does not prevent sepsis in preterm or very low birth weight infants. Details: A small clinical study in low birth weight infants shows that giving bovine colostrum (Pedimmune, Merk India Ltd.) 1.2 or 2 grams enterally four times daily until discharge or death does not reduce the risk of sepsis when compared with placebo (92411). Another small clinical study in formula-fed, preterm neonates also shows that giving bovine colostrum (Immuguard, Dulex-Lab) for 2 weeks has no effect on the incidence of late-onset sepsis when compared with a control group. While the severity of sepsis appeared to be higher in the control group, the study was underpowered to assess this outcomes (105755). An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not reduce the risk of sepsis when compared with a conventional milk fortifier (111140).
Short bowel syndrome. Small clinical studies suggest that oral bovine colostrum is not beneficial in children or adults with short bowel syndrome. Details: A very small crossover study in children with short bowel syndrome shows that administering bovine colostrum enterally at a dose that comprises 20% of a child's daily basal fluid requirement does not improve growth or intestinal function when compared with a control diet (92410). Another very small crossover study in adults with short bowel syndrome shows that taking bovine colostrum 250 mL twice daily for 4 weeks does not improve intestinal absorption or body composition when compared with an isocaloric control supplement (92423).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Aging. Although there has been interest in using oral bovine colostrum for aging, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Athletic performance. Small clinical studies suggest that oral bovine colostrum might improve some measures of athletic performance; however, results are mixed, and any benefit appears to be small. Details: Several small clinical studies show that taking bovine colostrum 10-60 grams daily for up to 8 weeks increases power and improves cycling and sprint time following an initial bout of exercise, but not during a normal training period (11453,16532,36988,36991,36995). Another small clinical study in elite soccer players shows that a lower dose of 3.2 grams daily for 6 weeks modestly attenuates muscle damage, muscle soreness, and decreases in squat jump performance after simulated soccer matches (98820). However, bovine colostrum does not appear to improve rowing performance, anaerobic work capacity, endurance, or strength training (11453,16532,36980,36992,36995,37000,37006,92419,114817). Differences are possibly explained by the variation in exercise and recovery protocols used (16533).
Autism spectrum disorder. Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A very small clinical trial in children aged 3-11 years with autism spectrum disorder shows that taking bovine colostrum (Immucon) 5.1-10.8 grams daily with Bifidobacterium infantis for 5 weeks improves measures of irritability and hyperactivity and symptoms of autism-associated gastrointestinal problems such as stool consistency and frequency of diarrhea when compared to baseline (101792). The validity of these findings is limited by a lack of placebo control. Also, it is unclear if these findings are due to bovine colostrum, Bifidobacterium infantis, or the combination.
Benign prostatic hyperplasia (BPH). Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An open-label study in males with lower urinary tract symptoms related to BPH shows that taking bovine colostrum 30 mg and saw palmetto extract 320 mg plus tamsulosin 0.4 mg daily for 12 months does not improve overall symptoms when compared with tamsulosin alone. However, the combination improved storage symptoms more than tamsulosin alone, without affecting urinary flow rate, postvoid residual volume, or prostate volume (101795). This study is limited by the lack of a placebo group.
Chemotherapy-related infection. It is unclear if oral bovine colostrum is effective for the prevention of chemotherapy-related infection. Details: A small clinical study in children with leukemia shows that taking bovine colostrum (Biofiber-Damino) 0.5-1 gram/kg daily during chemotherapy treatment for 4 weeks does not reduce the incidence of fever, neutropenic fever, bacteremia, fungaemia, or the need for antibiotics when compared with placebo (101797). It is possible that this study was underpowered to detect between-group differences.
Child growth. Oral bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical trial in 9-month-old breastfed infants at high risk for stunted growth shows that giving bovine colostrum 5.7 grams with whole egg powder 4.3 grams twice daily for 3 months reduces stunting and linear growth faltering, as measured by mean length-for-age z-score, when compared with placebo. These effects are sustained for up to 5 months following discontinuation of bovine colostrum (105754). It is unclear if these effects are due to bovine colostrum, whole egg powder, or the combination.
Cognitive function. It is unclear if oral bovine colostrum is effective for improving cognitive function. Details: A small clinical study in older adults shows that taking a specific bovine colostrum product (Eterna Gold, Saskatoon Colostrum Co. Ltd.) 60 grams daily for 8 weeks does not improve cognitive function when compared with whey protein (92414).
Critical illness (trauma). It is unclear if oral bovine colostrum is beneficial in patients with critical illness. Details: A small clinical trial in critically ill patients shows that taking bovine colostrum 20 grams daily in enteral formula reduces the median length of stay by around 7 days and reduces risk of diarrhea by 72% when compared with placebo. There was no effect on vomiting, abdominal distention, constipation, sepsis, or mortality (101799).
Dental plaque. Although there has been interest in using topical bovine colostrum for dental plaque, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Diabetes. It is unclear if oral bovine colostrum is beneficial in patients with type 2 diabetes. Details: A very small clinical study in patients with type 2 diabetes shows that taking bovine colostrum (Immuno-Dynamics, Inc.) 5 grams twice daily on an empty stomach for 4 weeks decreases postprandial blood glucose by 11% to 14% and cholesterol levels by 8% when compared to baseline (92418). The validity of these findings is limited by a lack of comparator group.
Dry eye. Although there has been interest in using topical bovine colostrum for dry eye, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Graft-versus-host disease (GVHD). Although there has been interest in using oral bovine colostrum for diarrhea associated with GVHD, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Hematopoietic stem cell transplant (HSCT). Oral and topical bovine colostrum have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: A small clinical study in patients undergoing HSCT shows that taking a specific combination product containing bovine colostrum and aloe (Remargin Colostrum Gastro-Gel, Solimè srl) and rinsing with a specific mouthwash containing bovine colostrum and aloe (Remargin Colostrum OS, Solimè srl) modestly reduces the risk and duration of severe oral mucositis and febrile neutropenia when compared with historical values. There was no effect on duration of neutropenia, length of hospital stay, pain, or duration of medication use. All patients were also given standard care. The mouthwash was used after each oral hygiene session, and the oral treatment was taken 3 to 5 times daily depending on symptoms (110211,111135). The validity of these findings is limited by a lack of control group. Additionally, it is unclear if these findings are due to bovine colostrum, aloe, or the combination.
Human papillomavirus (HPV). It is unclear if intravaginal bovine colostrum is beneficial in patients with HPV infection. Details: Observational research in patients with HPV infection has found that vaginal application of bovine colostrum-containing tablets (Ginedie, Tfarma) twice weekly for 6 months is associated with regression of low grade cervical lesions in 76% of patients (92424). The validity of these findings is limited by the observational nature of the study and a lack of comparator group.
Influenza. It is unclear if oral bovine colostrum is effective for the prevention of influenza in adults. Details: A small clinical study in healthy Italian adults shows that taking a specific type of defatted freeze-dried bovine colostrum (ARd Colostrum, Corcon srl) 400 mg daily for 8 weeks reduces the rate of self-reported flu symptoms by approximately 70% to 75% when compared with no prophylaxis or receiving the influenza vaccine. In high-risk patients with cardiovascular disease, taking bovine colostrum, with or without influenza vaccination, reduces the rate of self-reported flu symptoms by up to 22% when compared with vaccination alone. However, viral testing was not conducted and some patients reported more than one incidence of flu symptoms during the study period, indicating that the reported symptoms might not have been caused by influenza infection (92412).
Lichen planus. Although there has been interest in using topical bovine colostrum for lichen planus, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Malnutrition. It is unclear if oral bovine colostrum is beneficial in children with malnutrition. Details: A small clinical study in children with nonorganic failure to thrive shows that taking bovine colostrum 40 mg/kg daily for 3 months, along with routine treatment, modestly increases weight but not height when compared with routine treatment alone. Failure to thrive resolves in approximately 10-fold more patients treated with bovine colostrum and routine treatment when compared with routine treatment alone (92420).
Multiple sclerosis (MS). It is unclear if oral bovine colostrum is beneficial in patients with MS. Details: A very small clinical study in patients with MS shows that taking hyperimmune bovine colostrum 100 mL daily for about 4 weeks improves symptoms of MS when compared with non-hyperimmune bovine colostrum (37039). However, another very small clinical study in patients with MS shows that taking hyperimmune bovine colostrum about 120 mL daily for 4 weeks does not improve symptoms of MS when compared with placebo (37024).
Muscle strength. Although there has been interest in using oral bovine colostrum for muscle strength, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Oral mucositis. It is unclear if oral bovine colostrum is effective for the prevention of chemotherapy-induced oral mucositis. Details: A small clinical study in children with leukemia shows that taking bovine colostrum (Biofiber-Damino) 0.5-1 gram/kg daily during chemotherapy for 4 weeks reduces the peak severity of oral mucositis, but not the overall risk of oral mucositis, when compared with placebo (101797).
Physical performance. It is unclear if oral bovine colostrum is effective for improving physical performance in older adults. Details: A small clinical study in older adults participating in resistance training shows that taking a specific bovine colostrum product (Eterna Gold, Saskatoon Colostrum Co. Ltd.) 60 grams daily for 8 weeks might improve leg strength, but not upper body strength or body composition, when compared with placebo (92414).
Prematurity. It is unclear if oral bovine colostrum improves outcomes in very preterm infants. Details: An open-label trial in very preterm infants shows that adding 1-2.8 grams of powdered bovine colostrum to each 100 mL of breastmilk until 35 weeks' postmenstrual age does not increase weight, length, or head circumference, but slightly improves bowel habits, when compared with a conventional milk fortifier (111140,111141). A large, multi-center, clinical study conducted in 7 neonatal intensive care units in China among very preterm infants shows that adding bovine colostrum to breastmilk, when maternal milk supply was insufficient, until postnatal day 14does not reduce time to full enteral feeding, feeding intolerance, risk of morbidity or mortality, or improve infant growth when compared with preterm formula added to breastmilk (114816). However, results significantly varied by study site where different feeding protocols were used. Additionally, blinding of clinical personnel was inadequate due to color, odor, and viscosity differences between bovine colostrum and preterm formula.
Psychological well-being. Although there has been interest in using oral bovine colostrum for psychological well-being, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Shigellosis. It is unclear if oral bovine colostrum is beneficial in children with shigellosis. Details: A small clinical study in children aged 1-12 years with shigellosis shows that taking hyperimmune bovine colostrum 100 mL three times daily for 3 days along with the antibiotic pivmecillinam for 5 days does not reduce the duration of Shigella dysenteriae infection when compared with a control group taking non-hyperimmune bovine colostrum and pivmecillinam (36986).
Sjogren syndrome. Although there has been interest in using topical bovine colostrum for Sjogren syndrome, there is insufficient reliable information about the clinical effects of bovine colostrum for this purpose.
Travelers' diarrhea. Several very small clinical studies suggest that oral hyperimmune bovine colostrum is beneficial for the prevention of travelers' diarrhea in adults. Details: Three very small clinical studies in healthy adults show that taking hyperimmune bovine colostrum reduces the risk of diarrhea due to pathogens that commonly cause travelers' diarrhea such as enterotoxigenic Escherichia coli (2068,2069) and Shigella flexneri (2070).
Ulcerative colitis. It is unclear if rectal bovine colostrum is beneficial in patients with ulcerative colitis. Details: A very small clinical study in patients with distal ulcerative colitis shows that rectal administration of bovine colostrum 10% solution, as an enema, twice daily along with oral mesalamine for 4 weeks improves symptom and histological scores when compared with a placebo enema plus mesalamine (9730).
Upper respiratory tract infection (URTI). It is unclear if oral bovine colostrum is effective for preventing or treating URTIs in children or adults. Details: A small clinical study in healthy adult males shows that taking a specific bovine colostrum product (Intact, Numico Research Australia Pty. Ltd.) 30 grams twice daily for 8 weeks reduces the incidence of URTIs by about 33% when compared with whey protein. However, it does not appear to reduce the duration of URTIs if they do occur (36998). However, another small clinical study in healthy medical and health sciences students shows that taking bovine colostrum 500 mg once or twice daily for 45 days, then again for 7 days starting at day 87, does not reduce the frequency or severity of URTI symptoms when compared with placebo (111139). In children aged 1-6 years with a history of recurrent URTIs, a small clinical study shows that taking hyperimmune bovine colostrum (ImmuGuard, NMI) 3 grams once or twice daily for 4 weeks decreases the occurrence of URTIs during a 6-month period by about 4 episodes when compared to baseline (95924). The validity of this finding is limited by the lack of a control group. However, another small clinical study in healthy children aged 3-7 years shows that taking bovine colostrum 500 mg twice daily for 15 days followed by 500 mg once daily for 30 days preventatively, and 500 mg twice daily for 4 days if URTI symptoms develped, does not decreases the frequency of days with any URTI symptoms and symptom severity over 21 weeks when compared with whey-based control. (114819). The validity of the study is limited by the lack of a true placebo and absence of investigator-rated outcomes. Frequency of URTIs and symptom severity was reported by the child's parents or guardians via online survey every 2-4 weeks throughout the duration of the trial.
Vaginal atrophy. Intravaginal bovine colostrum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in postmenopausal patients with vulvovaginal atrophy shows that inserting 2 mL of a combination cream (Refeel, IDI Pharma) containing bovine colostrum, visnadine, and prenylflavonoids into the vagina once daily for 15 days improves overall symptoms when compared to baseline (98819). A larger clinical study in postmenopausal patients shows that using an intravaginal gel containing bovine colostrum 2.3% and other ingredients (Monurelle Biogel, Zambon SpA) daily for 12 weeks improves overall vaginal health scores by approximately 54%, increasing the number of patients engaging in regular sexual activity to 84% from 59% at baseline. Use of the gel also appears to reduce urinary incontinence (101794). The validity of these findings is limited by the lack of control groups. Also, it is unclear if these effects are due to bovine colostrum, other ingredients, or the combination.
Wound healing. It is unclear if oral bovine colostrum is beneficial for wound healing. Details: A small non-randomized open-label intervention in patients with chronic non-healing wounds suggests that adding powdered bovine colostrum 500 mg to wound dressings for 21 days is associated with improved wound healing when compared with conventional wound dressings (114821). More evidence is needed to rate bovine colostrum for these uses.

(Read more about BOVINE COLOSTRUM)

CALCIUM

EFFECTIVE

Dyspepsia. Oral calcium carbonate is approved by the US Food and Drug Administration (FDA) as an antacid. Details: Taking calcium carbonate orally as an antacid is effective for treating dyspepsia (1843). Calcium carbonate has FDA approval as an antacid.
Hyperkalemia. Intravenous calcium gluconate is approved by the US Food and Drug Administration (FDA) for preventing hyperkalemia-induced cardiac abnormalities. Details: Administering calcium gluconate intravenously can reverse electrocardiographic changes and arrhythmias induced by hyperkalemia (12946). Intravenous calcium gluconate is FDA-approved for preventing hyperkalemia-induced cardiac abnormalities.
Hypocalcemia. Oral calcium treats and prevents hypocalcemia. Intravenous calcium is used to treat severe hypocalcemia. Details: Taking calcium orally is effective for treating and preventing hypocalcemia. Intravenous calcium gluconate, acetate, gluceptate, or chloride is effective for severe hypocalcemia or hypocalcemic tetany (12928).
Kidney failure. Oral calcium carbonate or calcium acetate is used as a phosphate binder during kidney failure. Details: Taking calcium carbonate or calcium acetate orally is effective as a phosphate binder. Calcium acetate (PhosLo) appears to control hyperphosphatemia better than sevelamer (Renagel) (12943,12944,38990). Calcium citrate is not recommended for this purpose because it increases aluminum absorption and does not bind phosphate as efficiently as calcium acetate or calcium carbonate (21631). Some clinical research also shows that taking calcium orally reduces blood pressure in patients with kidney failure (975).

LIKELY EFFECTIVE

Corticosteroid-induced osteoporosis. Oral calcium in combination with vitamin D prevents bone density loss that occurs during long-term treatment with corticosteroids. Details: Taking calcium in combination with vitamin D as adjunctive therapy seems to be effective for reducing bone mineral density loss in people using corticosteroids long-term (982,1046,1830,1831,1832,4462,4463,4464,4465,4466)(4467,12945,38493). One specific product used in clinical research is Oscal (Marion Merrel Dow Inc.), which contains elemental calcium 500 mg per tablet plus vitamin D 125 IU per tablet (982). Another product used is Oscal 250 + D (SmithKline Beecham Healthcare), which contains elemental calcium 250 mg and vitamin D 125 IU per tablet (1046).
Hyperparathyroidism. Oral calcium reduces parathyroid hormone levels in patients with secondary hyperparathyroidism due to kidney failure. Details: Taking calcium orally reduces parathyroid hormone levels in patients with kidney failure and secondary hyperparathyroidism (1827,1828,1829,39174,39425). In elderly women, the combination of calcium and vitamin D reverses secondary hyperparathyroidism and reduces hip fracture risk (8818). Also, population research suggests increased calcium intake from the diet and supplements reduces the risk of primary hyperparathyroidism in women. Supplemental intakes of at least 500 mg/day and dietary intakes of approximately 1100 mg/day are considered to be protective (91353).
Osteoporosis. Adequate calcium intake, from the diet and/or supplements, is recommended for the prevention and treatment of osteoporosis. Details: The Bone Health and Osteoporosis Foundation (BHOF) recommends ensuring adequate calcium intake in line with the recommended dietary allowance (RDA) by age, along with adequate vitamin D intake, for the prevention and treatment of osteoporosis in adults over 50 years of age. Supplementation can be used to augment dietary intake when adequate dietary intake is not feasible (109425). In the US and Canada, foods containing at least 200 mg calcium with less phosphorous content than calcium can be labelled with a health claim regarding the relationship between adequate calcium intake and a reduced risk for osteoporosis (11940,102148). However, calcium supplementation is not recommended specifically for the primary prevention of osteoporosis. The US Preventive Task Force (USPSTF) states that the current evidence is insufficient to assess the balance of benefits and harms of vitamin D and calcium supplementation, alone or in combination, for the primary prevention of fractures in community dwelling adults without osteoporosis (95695). Also, calcium supplements do not seem to be effective for preventing loss of bone mineral density (BMD) during lactation (988), in patients who have had bone marrow transplantation (1817), or in patients who have had renal transplantation (4823,38736,38871). Maximal bone growth occurs in the teenage years, and then BMD in females remains relatively constant until age 30-40. After age 40, bone loss typically occurs at rates of 0.5% to 1% per year. In males, this occurs several decades later. Bone loss is more pronounced if dietary calcium intake is below the RDA, which is the case for many Americans (2571,2578). One meta-analysis of randomized controlled trials in healthy children 7-14 years old shows that fortifying food with calcium 250-1000 mg daily for up to 24 months modestly improves femoral neck BMD, but not hip or spine BMD. However, the included trials did not supplement vitamin D (107232). During the 5 years immediately after menopause, calcium supplementation has very little effect on bone loss (2569,2570,2575,2576). The rapid loss of estrogen causes a high bone resorption rate, which increases serum calcium levels and therefore decreases intestinal absorption of calcium (2570). After this period, the typical rate of bone loss is 2% per year (2572,2576). Taking calcium 1000-1600 mg daily as carbonate, citrate, lactate gluconate, or citrate malate salt decreases this rate by 0.25% to 1% annually (977,979,981,2569,2571,2572,2575,2576,2578,6850)(38978,38980,39064). The greatest reductions (1% or more) are seen in the first 1-2 years of supplementation when bone remodeling foci can be filled (2569,2576). After this period, the differences in rate of loss between supplemented and non-supplemented females are closer to 0.25% per year (2569,2577). A meta-analysis of clinical evidence suggests that there is no additional benefit after 4 years (38980). Small clinical studies have found that continuous calcium supplementation at an average daily dose of 1050 mg, started after menopause and continued for 1.5-4 years, may reduce fracture rates by 26% when compared with no calcium supplementation. The largest of these studies was conducted in nursing home residents who also received daily vitamin D; the benefits of calcium, specifically, are unclear (39386). Some research also suggests that calcium and vitamin D improves primary prevention of osteoporotic fractures in some older individuals with osteoporosis, particularly the elderly and those who are no longer community dwelling (12930,38875,38849,39026,109471). However, not all research is positive. One large clinical trial in elderly adults with a low-trauma fracture show that taking calcium 1000 mg daily with or without vitamin D 800 IU daily for 2-7 years does not reduce the risk of a second fracture when compared with placebo (13073). Another clinical study shows that taking calcium 1000 mg daily plus vitamin D 800 IU daily does not prevent a second fracture in elderly patients, or prevent a first fracture in elderly patients with other risk factors such as low body weight (less than 58 kg, 127.6 pounds), smoking, family history of hip fracture, or fair or poor self-reported health (12929). Also, some exploratory research suggests that supplements may need to be continued indefinitely; in adults over 68 years of age, any effects of 2 years of calcium supplements on BMD appear to be lost within 2 years after discontinuing supplements (6853). Calcium has additive effects when used with other agents such as vitamin D, estrogens, or calcitonin. Whereas calcium alone generally reduces or prevents loss of BMD, combination with other agents can produce small increases in BMD ranging from 0.3% to 3.3% depending on the combination and dosages used (978,980,1836,2570,2571,2572,2576). However, one meta-analysis in healthy adults shows that fortifying foods with calcium 250-1000 mg daily, in conjunction with vitamin D supplementation, for up to 24 months does not improve BMD when compared with control (107232). The full potential of osteoporosis treatments cannot be realized without adequate calcium intake (2569,2570,2571,2572). Advise patients taking agents such as estrogens, calcitonin, bisphosphonates, or raloxifene (Evista) to ensure that their daily calcium intake meets the RDA. Use supplements if necessary. The usefulness of calcium in preventing osteoporosis in males is not as well-studied. Some observational research has found that calcium 870 mg daily is not associated with changes in BMD and bone loss in males (97201). However, clinical evidence suggests that taking calcium 1000 mg daily for 2 years might improve trabecular or cortical bone mass by 2% to 4% (980,8827,8873). Dietary supplementation with calcium and vitamin D seems to moderately reduce bone loss measured in the femoral neck, spine, and total body, and seems to reduce the incidence of nonvertebral fractures in older patients with osteopenia or low BMD (980).
Premenstrual syndrome (PMS). Adequate calcium intake seems to prevent symptoms of PMS. Details: There seems to be a link between low dietary calcium intake and symptoms of PMS (2004,6847,39007). Taking calcium 1000-1336 mg daily seems to significantly reduce depressed mood, water retention, and pain, especially if daily calcium intake is inadequate (1822,1823,1824,2004,95821). Calcium carbonate 1200 mg daily seems to decrease PMS symptom scores by about 18% when compared with placebo (1822). Increasing dietary calcium intake is also associated with a decreased risk of developing PMS. Consuming an average of 1283 mg of calcium per day from foods is associated with about a 30% lower risk of developing PMS compared with consuming an average of 529 mg daily (13094); however, taking calcium supplements does not appear to be associated with the risk of developing PMS.

POSSIBLY EFFECTIVE

Colorectal cancer. Oral calcium seems to be beneficial for preventing colorectal cancer, especially in those with adequate vitamin D levels and normal body mass index (BMI). Details: Population studies have found that increased intake of dietary or supplemental calcium is associated with a reduced risk of colorectal cancer and colorectal adenomas (1047,8820,12120,38951,98898,98899). Clinical trials and meta-analyses of clinical research also show that taking calcium supplements 1.2-2 grams daily for up to 4 years can reduce the risk of colorectal adenoma recurrence by up to 29% (970,12118,12950,15267,34596,38718,39042,95817). However, not all research has been positive. Some meta-analyses of clinical research or observational studies suggest that taking calcium does not reduce the risk of familial adenomatous polyposis or colorectal cancer (34596,39042,39349). Other contradictory research suggests that postmenopausal females who take calcium 1000 mg daily plus vitamin D 400 IU daily do not have a reduced risk of developing colorectal cancer (14290); however, this finding may not be reliable due to the high baseline intake of calcium in study participants. The reason for these conflicting findings is not entirely clear. Vitamin D might be an important factor. People with lower than average vitamin D levels do not seem to get any benefit from calcium supplements (12118). Also, one meta-analysis of previous trials suggests that taking calcium 1200 mg daily reduces the risk of colorectal adenomas in people with a normal BMI, but not in those who are overweight or obese (99715). Despite this conflicting evidence, the US Food and Drug Administration (FDA) approved a qualified health claim in 2005 stating that calcium supplements may reduce the risk of colorectal cancer and colorectal adenomas. However, the FDA has determined that there is little scientific evidence to support this claim (102366).
Fetal bone mineralization. If calcium intakes are low during pregnancy, oral calcium seems to be beneficial for increasing fetal bone density. Details: With low dietary calcium intake (less than 562 mg elemental calcium daily) during pregnancy, calcium supplementation increases fetal bone mineralization and density. However, calcium supplementation does not offer any additional benefit if calcium intakes are adequate (3263,3264).
Hypertension. Oral calcium seems to reduce blood pressure by a small amount in adults with or without hypertension. However, it is unclear if this reduction is clinically significant. Details: Many clinical trials and observational studies, including a meta-analysis of 18 high-quality clinical trials, show that intake of calcium supplements or dietary calcium modestly reduces systolic blood pressure in patients with or without hypertension, usually around 1-2 mmHg. Calcium seems to be more effective for certain subpopulations of patients, such as those who are salt-sensitive or have low baseline dietary calcium intake (945,972,974,976,984,1818,1819,1820,1821,6852)(13138,14406,38803,39063,39094,39221,113920,113925). However, a large-scale clinical trial in postmenopausal females shows that taking vitamin D (cholecalciferol) 400 IU daily in combination with elemental calcium 1000 mg daily does not lower blood pressure or reduce the risk of developing hypertension (16714). Additionally, a meta-analysis of 8 clinical trials shows that taking calcium in combination with vitamin D for up to 7 years has no effect on blood pressure (98861). The validity of this finding is limited by the poor methodological quality of the included studies. Some observational research suggests that calcium can reduce the risk for hypertension. Population research in females aged 45 years and older suggests that higher intake of calcium from both diet and supplemental sources is linked to a lower risk of developing hypertension when compared to lower calcium intake (14265). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim stating that calcium supplements may reduce the risk of hypertension. However, the FDA has concluded that this claim is based on supporting, rather than conclusive, evidence (102367). Research evaluating the effect of calcium supplementation during pregnancy on the child's blood pressure has yielded conflicting findings. A systematic review of 2 clinical studies and 3 observational studies found that calcium intake during pregnancy is associated with a 1-2 mmHg reduction in the systolic blood pressure of the offspring between the ages of 1-7 years (38852). However, a separate meta-analysis of 3 clinical studies shows that calcium intake during pregnancy does not reduce systolic or diastolic blood pressure in the offspring (113923).
Osteomalacia. Oral calcium seems to reverse osteomalacia caused by very low calcium intakes. Details: Osteomalacia is commonly caused by vitamin D deficiency; however, very low calcium intake can also lead to osteomalacia in children and adults. Calcium supplementation can reverse osteomalacia caused by calcium deficiency. Along with appropriate vitamin D supplementation, individuals at risk of osteomalacia need sufficient calcium intake (94819).
Pre-eclampsia. Oral calcium seems to reduce the risk of pre-eclampsia, especially in high-risk individuals and those with low baseline dietary calcium intake. Details: Although there is some conflicting evidence (971,38756), most clinical research shows that taking calcium orally 1-2 grams daily reduces the risk of pre-eclampsia (973,1833,8828,39043,39319,39426,97348,113919). A large clinical trial of 11,000 pregnant individuals in India and Tanzania shows that supplementation with 500 mg daily is similarly effective to 1500 mg daily (113908). Multiple meta-analyses which include 16-30 clinical studies have found that varying doses of calcium supplementation reduce the relative risk of pre-eclampsia by 46% to 51% when compared with placebo (97348,113909,113919). One of these meta-analyses found that for every 19 females treated with calcium, one episode of pre-eclampsia would be avoided (97348). Additionally, one of these meta-analyses found that calcium reduces the relative risk of pre-eclampsia by 51%, regardless of whether it is taken at a dose above or below 1000 mg daily (113919). Some research suggests that calcium supplementation may have a greater effect in individuals at high risk of pre-eclampsia or with low baseline dietary calcium intake, and when taken at greater than or equal to 20 weeks of gestation (15029,38497,97348,99714,113919). However, another meta-analysis of 30 clinical studies found a similar benefit of calcium in both high- and low-risk individuals (113919). A separate meta-analysis of 6 clinical studies conducted in China evaluated the benefits of calcium carbonate 500-600 mg daily taken in conjunction with aspirin 50-75 mg daily during pregnancy. This combination was associated with an 80% lower relative risk of pre-eclampsia and an 83% lower relative risk of pre-eclampsia with gestational hypertension when compared with routine care (113913). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim regarding the use of calcium supplements to reduce the risk of pregnancy-induced hypertension and pre-eclampsia. However, due to the limited and conflicting research available at that time, the FDA stated that this outcome was highly unlikely (102366). Since then, large, high-quality clinical research has supported this finding. In fact, in 2016 the World Health Organization (WHO) released a recommendation to prescribe oral calcium 1.5-2 grams daily during pregnancies at high risk of pre-eclampsia if dietary calcium intakes are low (97347).
Pregnancy-induced hypertension. Oral calcium may reduce the risk of pregnancy-induced hypertension. Details: A meta-analysis of 17 clinical studies shows that calcium supplementation during pregnancy may reduce the relative risk of pregnancy-induced hypertension by 30% when compared with control (113909). A separate meta-analysis of 6 clinical studies conducted in China, which evaluated the benefits of calcium carbonate 500-600 mg daily taken in conjunction with aspirin 50-75 mg daily during pregnancy, shows that this combination reduces the relative risk of pregnancy-induced hypertension by 85% when compared with routine care (113913).
Rickets. Oral calcium seems to reverse rickets caused by very low calcium intakes. Details: Rickets is commonly caused be vitamin D deficiency; however, very low calcium intake can also lead to rickets. Calcium supplementation can reverse rickets caused by calcium deficiency (94819). A small clinical study in children with nutritional rickets shows that taking calcium 500-2000 mg daily for 24 weeks improves radiographically measured rickets caused by calcium deficiency. Rickets seems to improve more rapidly with calcium 1000 mg compared to calcium 500 mg. However, increasing the calcium dose to 2000 mg daily is not more beneficial than calcium 1000 mg daily (98904).
Tooth retention. Oral calcium with vitamin D seems to help with tooth retention in the elderly population. Details: A clinical trial in the elderly population shows that taking calcium citrate malate 500 mg daily along with vitamin D3 (cholecalciferol) 700 IU daily orally for 3 years reduces the risk of tooth loss by about 52% when compared with placebo (8816).

POSSIBLY INEFFECTIVE

Breast cancer. Oral calcium, via supplementation or as part of the diet, does not seem to be beneficial for breast cancer prevention. Details: Although some studies disagree (15631,39041,95811,107237,113917), most population research suggests that increased calcium intake is not associated with overall breast cancer risk (15631,16715,98895,107236,107237,113917). However, one meta-analysis of observational studies shows that although higher total calcium intake is not associated with breast cancer risk, higher dietary calcium intake, specifically, may be associated with a slightly reduced risk (113917). Also, some analyses suggest that calcium intake may be associated with the risk for certain breast cancer sub-types. Some subgroup analyses suggest that calcium intake may reduce the risk of breast cancer in postmenopausal, but not pre-menopausal, adults (15631,107237) and that dietary calcium intake may reduce estrogen receptor(ER)-negative breast cancer, but not ER-positive breast cancer (107236). However, most research has not evaluated the effects of calcium supplementation or intake on breast cancer subtypes. The best evidence to date, from a large scale clinical trial (Women's Health Initiative), shows that taking vitamin D (cholecalciferol) 400 IU daily plus calcium 1000 mg daily for 7 years after menopause does not reduce the risk of developing invasive breast cancer at the end of the study and 5 years after the end of the intervention (16715,98895).
Fractures. Although oral calcium prevents fractures in osteoporosis, most evidence shows that calcium does NOT prevent factures in people who do not have osteoporosis. See Osteoporosis discussion for more information on the use of calcium for this purpose. Details: Robust meta-analyses of mostly large, high-quality clinical studies show that calcium supplementation 500-1600 mg daily for 0.5-7 years with or without vitamin D does not reduce total fractures, hip fractures, vertebral fractures, or non-vertebral fractures in older adults without osteoporosis (95822,112486). A large-scale study in postmenopausal females aged 50-79 years who were enrolled in the Women's Health Initiative (WHI) suggests that calcium 1000 mg plus vitamin D 400 IU daily for 7 years only modestly improves bone mineral density (BMD) and does not significantly reduce fracture risk. This lack of effect may have been due to low adherence to the treatment regimen. In those who were 80% adherent, the combination of calcium plus vitamin D reduced the risk of hip fracture by about 29% (14282). Also, some clinical research shows that taking calcium carbonate 1000 mg and vitamin D 400 IU for 5 years does not attenuate loss of height after menopause when compared with placebo (95810). Additional meta-analyses of clinical and observational evidence suggest that calcium supplementation is not associated with a reduced risk of vertebral or nonvertebral fractures, such as hip fractures (38589,38888,98895). Some other research has suggested that calcium in combination with vitamin D reduces fracture risk in older patients without osteoporosis (980,1836,8818,12930,12933,12952,38849,102145,107235); however, this research is confounded by a number of variables, including the presence of hormonal therapy and differing levels of fracture risk at baseline (1836,8818,95822). Conflicting findings on this topic might also be due to genetic differences in patient populations. A population analysis of the WHI study found that, in older females with the lowest genetic susceptibility to low BMD, taking calcium with vitamin D is associated with a reduction in fracture risk. However, in females with a higher genetic susceptibility to low BMD, there is no association between supplementation and fracture risk. This might be because individuals with a lower susceptibility to low BMD are also more responsive to calcium and vitamin D supplementation (97357). As of April 2018, the U.S. Preventative Services Task Force (USPSTF) concludes that there is insufficient evidence to determine whether supplementing with vitamin D >400 IU daily along with calcium >1000 mg daily is safe and effective for preventing fractures in community dwelling adults without vitamin D deficiency, osteoporosis, or a history of fracture. USPSTF recommends against supplementing with calcium 1000 mg daily or less along with vitamin D 400 IU daily or less for preventing primary fractures in community-dwelling postmenopausal females (95695).
Obesity. Oral calcium does not seem to improve weight loss in adults or children with overweight or obesity. Details: Observational research has found that adults and children with low calcium intake are more likely to gain weight, have a higher body mass index (BMI), and be overweight or obese when compared to people with high calcium intake (12124,12125,12126,12127,14265). Additional observational research has found that increasing calcium intake is associated with weight loss in females; the results in males have been conflicting (12127,15602,15603). Despite these findings from observational research and a few small clinical studies (12128,15397,14438,98905,113918), most clinical research has found that increased calcium intake does not increase weight loss (12052,13138,15396,15399,38985,39004,97356). A meta-analysis of 20 clinical studies shows that daily dietary and supplemental calcium intake that meets the dietary reference intake (DRI) of 1000 mg or more daily does not increase weight loss in overweight individuals or patients with obesity when compared with intake below the DRI (95813). An older meta-analysis of 13 clinical trials also shows that increased dietary and supplemental calcium intake does not increase weight loss (15605).
Overall mortality. Oral calcium does not seem to reduce overall mortality. Details: While some population research has found that calcium taken in combination with vitamin D in older females is associated with a lower risk of death (97353), most evidence shows that calcium, with or without vitamin D, has no effect on all-cause mortality (93533,97308,113584).

INEFFECTIVE

Cardiovascular disease (CVD). Oral calcium does not reduce the risk of developing CVD and may actually increase risk in some patients. Details: Clinical research shows that calcium does not decrease CVD risk. Several separate meta-analyses of clinical and population research involving over 50,000 patients show that taking calcium 600-1200 mg daily for up to 7 years does not reduce the risk of CVD-related outcomes, including stroke and myocardial infarction, cardiovascular death, or overall mortality (39018,91350,92994,93533,97308,98902,107231,107233). No association was found between total dietary or supplemental calcium intake with or without vitamin D and the risk of CVD or mortality (91350,93533,97308). In fact, some population and clinical research has found that when calcium is used alone or with vitamin D, there is an INCREASED risk of CVD and coronary heart disease (38077,107233). However, other clinical research disagrees (93533). One meta-analysis of high-quality randomized controlled trials shows that taking calcium for 2-7 years increases the risk of CVD and coronary heart disease by 1.1-1.2 times when compared with control. However, the majority of the included research evaluated postmenopausal females and it is unclear if this finding is applicable to other populations (107233).
Chemotherapy-induced peripheral neuropathy. Intravenous calcium does not prevent nerve pain in patients given oxaliplatin. Oral calcium has not been evaluated for this purpose. Details: While pooled analyses of cohort studies and randomized controlled trials suggest that calcium and magnesium infusion decreases the incidence of oxaliplatin-induced neurotoxicity, a meta-analysis of only randomized controlled trials shows that the infusion has no effect in preventing neurotoxicity (90028,90029,90031). Additionally, clinical trials show that administering calcium gluconate 1 gram with magnesium sulfate 1 gram intravenously immediately before, or before and after, the administration of a single oxaliplatin cycle (90005), or over the entire 6-cycle course of oxaliplatin, does not improve symptoms of neurotoxicity when compared with placebo (96474).
Myocardial infarction (MI). Oral calcium does not prevent MI. When taken in the absence of vitamin D, oral calcium may increase the risk of MI. Details: Population research has found that increased dietary intake of calcium is associated with a decreased risk of MI (91350). However, a 2010 meta-analysis of clinical research shows that taking calcium at a dose of at least 500 mg daily is associated with an approximate 30% INCREASE in the risk of MI in patients over the age of 40. According to this analysis, one additional case of MI will occur for every 69 patients that take calcium for 5 years (17482). A more recent meta-analysis of high-quality randomized controlled trials shows that taking calcium for 2-7 years increases the risk of MI by 1.2 times when compared with control. However, the majority of the included research studied postmenopausal females and it is unclear if this finding is applicable to other populations (107233) In contrast, other meta-analyses of clinical research have shown that taking calcium for up to 7 years is NOT associated with an increased risk of MI, including a meta-analysis that only included postmenopausal females (93533,107231). Reasons for these discrepancies are not entirely clear. It may relate to whether calcium is taken as monotherapy or in combination with vitamin D. When taken with vitamin D, which is commonly recommended, calcium supplementation does not appear to be associated with an increased risk of MI in postmenopausal females (93533). Also, the association between calcium supplementation and MI risk may be influenced by the amount of calcium consumed as part of the diet. Supplementation with calcium may be associated with an increased risk of MI in people with dietary calcium intake above 805 mg daily, but not in those with dietary calcium intake below 805 mg daily (17482)

INSUFFICIENT RELIABLE EVIDENCE to RATE

Alcohol use disorder. It is unclear if oral calcium is beneficial for alcohol use disorder. Details: Preliminary clinical research shows that taking calcium carbonate 800 mg and vitamin D 200 IU orally daily for 14 days modestly reduces alcohol craving scores and withdrawal scores when compared with placebo in adults with alcohol dependence that are undergoing withdrawal. Taking calcium carbonate did not reduce the need for diazepam; however, the study may have been inadequately powered to detect a difference between groups (107234).
Atherosclerosis. It is unclear if oral calcium is beneficial for atherosclerosis. Details: A population study has found that taking calcium 1.2 grams daily for 3 years has no effect on carotid intima thickness or carotid atherosclerosis incidence. A total calcium intake (dietary and supplemental) of at least 1794 mg daily in older females may be associated with a decreased risk of carotid atherosclerosis when compared with a total calcium intake below 1010 mg daily (97351).
Autism spectrum disorder. It is unclear if oral calcium during pregnancy is beneficial for reducing the odds of autism spectrum disorder in the offspring. Details: A small observational study found that calcium supplementation during pregnancy is associated with a 52% reduced odds of an autism spectrum disorder in the offspring (98900).
Brain tumor. It is unclear if dietary calcium intake is associated with risk of brain tumor. Details: A meta-analysis of 4 case-control studies has found that higher dietary calcium intake is associated with a lower odds of brain tumor when compared with lower dietary intake (113922). The validity of this finding is limited by the exploratory nature of the included studies, which analyzed all dietary ingredients for any potential associations.
Cancer. Oral calcium alone does not seem to prevent cancer. It is unclear if oral calcium with vitamin D is beneficial for preventing cancer. Details: Taking calcium alone does not seem to significantly reduce the risk of cancer (12118,15629). The role of calcium in cancer prevention when taken along with vitamin D is controversial, as conflicting results exist. One clinical trial shows that healthy postmenopausal females who take supplemental calcium 1400-1500 mg daily plus vitamin D3 (cholecalciferol) 1100 IU daily have a 60% lower relative risk for developing cancer of any type. Approximately 25 postmenopausal females would need to take this combination for 4 years to prevent one occurrence of cancer (15629). However, a more recent clinical study shows that healthy postmenopausal females who take supplemental calcium 1500 mg daily plus vitamin D3 (cholecalciferol) 2000 IU daily do not have a reduced risk of cancer at 4 years (93943). Reasons for the disparate results are not entirely clear. The discrepancies do not appear to be related to baseline vitamin D levels or different study populations. It is possible that, given the 10-year time lapse between the two publications, the discrepancies result from differences in cancer detection capability. Also, since cancer risk was a secondary outcome measure in the earlier study and a primary outcome measure in the more recent study, it is possible that the discrepancies result from differences in statistical methodologies. The effect of vitamin D and calcium on cancer risk in males and younger patients is not known. There is also interest in using calcium for reducing the risk of hematological malignancies. An analysis of the Women's Health Initiative study shows that taking calcium 1000 mg daily in combination with vitamin D3 400 IU for up to 10 years is associated with a 20% reduction in the risk of hematologic malignancies when compared with placebo. However, no effect on hematologic malignancy related mortality was seen (97354).
Depression. It is unclear if oral calcium is beneficial for depression prevention. Details: Population research has found no association between a higher dietary intake of calcium and the risk of depression when compared with a lower dietary intake of calcium (96480).
Diabetes. It is unclear if dietary calcium intake is associated with type 2 diabetes risk. Details: Some population research has found that a higher intake of calcium from the diet or supplements, alone or in combination with vitamin D, is associated with a lower risk of developing type 2 diabetes when compared with lower calcium intake (14265,16713,96473,113929). One meta-analysis of cohort and cross-sectional studies found that the highest level of dietary calcium intake is associated with an 18% relative reduction in risk of type 2 diabetes when compared with the lowest level of intake. A dose-response analysis suggests that each 300, 600, and 1000 mg per day increase in dietary calcium intake is associated with a 7%, 14%, and 23% reduced risk of type 2 diabetes, respectively (113929). However, population research is often limited by confounding variables. For example, one analysis suggests that any beneficial effect might be influenced by concomitant magnesium intake (96473,113929), while another suggests that any benefit from increased intake may be more pronounced in females, adults aged 50 years or older, and Asian populations (113929). Furthermore, other population research has found that serum calcium levels higher than 9.6 mg/dL are associated with greater risk of developing diabetes in Chinese adults with osteoporosis (95815).
Dyslipidemia. It is unclear if oral calcium is beneficial for dyslipidemia. Details: One clinical study in adults with mild to moderate hypercholesterolemia shows that adding calcium carbonate 400 mg three times daily to a low-fat diet (American Heart Association Step 1) for 6 weeks reduces low-density lipoprotein (LDL) cholesterol levels by 4% and increases high-density lipoprotein (HDL) cholesterol levels by 4% when compared with the low-fat diet and placebo (2557). In contrast, a clinical study in females with dyslipidemia shows that taking calcium 800 mg daily for 2 years INCREASES total cholesterol levels and carotid intima-media thickness in postmenopausal, but not premenopausal, females when compared with placebo (97350). Calcium supplementation has also been evaluated in combination with vitamin D. A meta-analysis of randomized controlled trials including adults with normolipidemia and dyslipidemia shows that taking calcium 500-2000 mg daily and vitamin D 200-7142 IU daily modestly improves HDL cholesterol and triglyceride levels, but not LDL cholesterol levels, when compared with placebo. Subgroup analyses suggest that calcium and vitamin D supplementation is most beneficial in patients with dyslipidemia at baseline (107227). The relationship between dietary calcium intake and serum lipid levels has also been evaluated in observational research. A meta-analysis of 7-11 observational studies found that dietary calcium intake is not associated with total cholesterol levels, although small differences in individual lipid parameters were identified. Additionally, a meta-analysis of 4-9 observational studies suggests that calcium intake is not associated with the risk of developing hypertriglyceridemia, hypercholesterolemia, or low HDL. A subgroup analysis found that higher calcium intake may be associated with lower triglyceride levels in Asian populations (113927). Overall, these findings are limited by significant heterogeneity and the cross-sectional nature of the included studies.
Dysmenorrhea. It is unclear if oral calcium is beneficial for reducing pain associated with dysmenorrhea. Details: Clinical research shows that taking calcium carbonate 1000 mg with vitamin D 5000 IU daily for three menstrual cycles does not reduce pain when compared with placebo in patients with primary dysmenorrhea (95821). However, calcium carbonate 1000 mg taken alone seems to reduce pain when compared with placebo.
Endometrial cancer. It is unclear if oral calcium is beneficial for endometrial cancer prevention. Details: A meta-analysis of population research suggests that calcium supplements may reduce the risk of endometrial cancer, but dietary calcium does not seem to have any effect (38893).
Exercise-induced muscle damage. It is unclear if oral calcium is beneficial for reducing exercise-induced muscle damage. Details: A very small clinical study in resistance-trained adults shows that taking calcium carbonate 500 mg 4 times daily for 3 weeks does not attenuate exercise-induced muscle damage from bench presses when compared with placebo (113933). This study may have been inadequately powered to detect a difference between groups.
Fall prevention. It is unclear if oral calcium with vitamin D is beneficial for preventing falls. Details: Research suggests that calcium in combination with vitamin D, but not calcium alone, might prevent falls by decreasing body sway and normalizing systolic blood pressure (6362,11939,39038). Some experts think the combination of calcium and vitamin D may be important (11916). Preliminary clinical research in adults residing in a health care facility shows that taking vitamin D supplements while increasing dietary calcium and protein for 2 years reduces falls by 11% when compared with standard diets. Intervention diets were supplemented with milk, yogurt, and cheese to provide calcium 1142 mg and protein 69 grams daily (107235). There might also be different effects in females compared to males. In one study, females aged 65 years or older who took vitamin D 700 IU plus calcium citrate 500 mg daily over a 3-year period had a 46% lower risk of falling. However, this combination did not decrease falls in males (14291).
Fluorosis. Oral calcium has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Taking calcium orally, in combination with ascorbic acid (vitamin C) and vitamin D, seems to be effective for reducing excessive fluoride levels in children and improving symptoms of fluorosis in children aged 6-12 years (990).
Heart failure. It is unclear if oral calcium in combination with vitamin D is beneficial for preventing heart failure. Details: Based on a secondary analysis of a large-scale clinical trial (Women's Health Initiative), taking calcium 1000 mg with vitamin D 400 IU daily does not reduce the risk of heart failure in the overall population or in individuals at high risk. However, in a subgroup of postmenopausal females without risk factors for heart failure, calcium and vitamin D supplementation might reduce the risk of developing heart failure by about 37% (97307).
Lead toxicity. It is unclear if oral calcium is beneficial for reducing blood levels of lead. Details: Lead is mobilized along with calcium from bone during pregnancy and lactation, resulting in increased serum concentrations of lead. One clinical study suggests that calcium supplementation does not significantly decrease these elevated lead concentrations (1586). However, another clinical study suggests that taking calcium reduces blood lead levels by 11% when compared with placebo, with greatest effects observed in those with high baseline levels of lead (38957).
Lyme disease. Although there is interest in using oral calcium for Lyme disease, there is insufficient reliable information about the clinical effects of calcium for this condition.
Metabolic syndrome. It is unclear if oral calcium alone or with vitamin D is beneficial for metabolic syndrome prevention. Details: Population research has found that a higher intake of calcium from diet and supplements alone, or in combination with vitamin D, is associated with a lower risk of developing metabolic syndrome when compared with lower calcium intake (14265,16713).
Nephrotic syndrome. It is unclear if oral calcium with vitamin D is beneficial for preventing nephrotic syndrome. Details: Clinical research shows that taking calcium 500-1000 mg daily for 3 months in combination with vitamin D3 60,000 IU daily or weekly for 4 weeks has no effect on bone mineral density or the risk of relapse in children with steroid-sensitive nephrotic syndrome (97355).
Nonmelanoma skin cancer. It is unclear if oral calcium is beneficial for preventing keratinocyte carcinomas. Details: In middle aged and older adults recently diagnosed with a colorectal adenoma, clinical research shows that taking calcium 1200 mg daily as calcium carbonate for 3-5 years does not reduce the incidence of keratinocyte cancer when compared with placebo over a median of 8 years. A sub-group analysis shows that taking calcium alone or with vitamin D3 1000 IU daily reduced the risk of invasive cutaneous squamous cell carcinoma by a moderate amount, but had no effect on the risk of basal cell carcinoma (104622).
Oral mucositis. When used in combination with fluoride treatments, a calcium phosphate mouth rinse seems to prevent and reduce mucositis-related pain in patients undergoing hematopoietic stem cell transplantation (HSCT). Details: A small clinical study in patients undergoing HSCT shows that using a particular mouth rinse (Caphosol, EUSA Pharma) containing calcium phosphate, in combination with fluoride treatments, reduces days of mucositis, the duration of pain, and the dose and days of morphine used when compared with placebo and fluoride treatment (38611).
Ovarian cancer. It is unclear if oral calcium is beneficial for ovarian cancer prevention. Details: An older meta-analysis of 12 cohort studies found that dietary calcium intake is not associated with a reduced risk of ovarian cancer (38792). However, a more recent pooled analysis of 15 cohort and case-control studies has found that the highest intake of dietary or dairy calcium is associated with a 20% lower risk of ovarian cancer when compared to the lowest intake (97349).
Postpartum depression. It is unclear if oral calcium is beneficial for reducing postpartum depression risk. Details: Preliminary clinical research shows that taking calcium 2 grams daily beginning at 11-21 weeks gestation reduces depression at 12 weeks postpartum when compared with placebo. However, no benefit is seen at 6 weeks postpartum (39447).
Pregnancy-related leg cramps. It is unclear if oral calcium is beneficial for preventing leg cramps during pregnancy. Details: A small clinical study shows that taking calcium 1 gram twice daily (as a mixture of salts) for 2 weeks can reduce pregnancy-related leg cramps during the second half of pregnancy when compared with no treatment (2567).
Prematurity. It is unclear if supplemental calcium is beneficial for the growth and development of preterm infants. Details: A small clinical study in preterm infants consuming human milk shows that supplementation with calcium 45 mg/kg daily and phosphorus 25 mg/kg daily does not affect infant weight, length, head circumference, or risk of osteopenia after 6 weeks when compared with human milk alone (113924). However, the duration and size of this study may have been too limited to detect any difference between groups.
Preterm labor. It is unclear if oral calcium reduces the risk of preterm labor. Details: A meta-analysis of 10 clinical studies shows that taking calcium supplements during pregnancy does not reduce the risk of preterm labor when compared with placebo (113909). A separate meta-analysis of 7 clinical studies conducted in China, which evaluated the benefits of calcium carbonate 500-600 mg daily taken in conjunction with aspirin 50-75 mg daily during pregnancy, shows that this combination reduces the relative risk of preterm labor by 74% when compared with routine care (113913).
Prostate cancer. It is unclear if oral calcium is beneficial for prostate cancer prevention. Details: Some clinical research shows that taking calcium 1200 mg daily might decrease the risk of developing prostate cancer (14133). However, some epidemiological research suggests that consuming very high doses of calcium, over 2000 mg daily, might actually increase the risk of developing prostate cancer (14134). Some epidemiological research also suggests that doses greater than 1500 mg daily increase the risk of poorly differentiated, clinically advanced, and fatal prostate cancer (14132). Consumption of dairy products has also been weakly linked to a modest increase in risk of prostate cancer (98894). However, contradictory research suggests that there is no association between dietary intake of calcium and overall risk of prostate cancer (14131,14132,104630).
Stroke. It is unclear if oral calcium is beneficial for stroke prevention. Details: Some population research has found that increasing dietary calcium intake is associated with a decreased risk of ischemic stroke (4822,38678). However, other population research has found that increasing dietary calcium intake is not associated with a decreased risk of stroke (91350). One meta-analysis of high-quality randomized controlled trials shows that taking calcium for 2-7 years does not affect the risk of stroke when compared with control. However, the majority of the included research evaluated postmenopausal females, and it is unclear if this finding is applicable to other populations (107233).
Vertigo. Oral calcium with vitamin D might reduce positional vertigo; the effect of calcium when used alone is unclear. Details: A large clinical study in adults with recurrent benign paroxysmal positional vertigo shows that taking calcium 500 mg and vitamin D 400 IU twice daily for one year reduces annual recurrence of vertigo by 27% when compared with no treatment. The number needed to treat to prevent vertigo was 3.7 (103681). It is unclear if this benefit is due to vitamin D, calcium, or the combination. More evidence is needed to rate calcium for these uses.

(Read more about CALCIUM)

INULIN

POSSIBLY EFFECTIVE

Constipation. Most clinical research shows that oral inulin modestly improves stool frequency, but may not improve discomfort, in adults and children with constipation. Details: A meta-analysis of clinical research in adults with constipation shows that consuming inulin improves stool frequency by approximately 0.7 stools per week. It also seems to improve stool transit time, consistency, and hardness, but does not reduce pain or bloating (93718). Additional clinical research shows that taking a specific type of inulin (OraftiGR, BENEO GmbH) 12 grams daily in three divided doses for 4 weeks increases stool frequency by approximately one stool per week when compared with a maltodextrin control. Taking inulin also reduces the number of patients experiencing hard and lumpy stools by 13%, but does not improve symptoms of bloating, distension, physical discomfort, or gas (96850). In children aged 2-5 years, one small clinical study shows that taking a specific combination of two inulin products (Orafti P95 oligofructose and Orafti GR inulin, BENEO GmbH), 2 grams twice daily in a dairy liquid for 6 weeks, improves the softness of stools, but not pain with stooling or stool frequency, when compared with a maltodextrin control (96848). Research in older adults is conflicting. One small study shows that taking inulin 20-40 grams daily for 19 days increases the number of stools from 1-2 per week to 8-9 per week (10415). However, other preliminary clinical research in this population shows that taking a specific inulin supplement (Fibruline Instant, Cosucra Groupe Warcoing) 15 grams daily in yogurt or stewed fruit for 4 weeks does not improve bowel symptoms, stool frequency, or stool consistency (93724).
Diabetes. Short-term use of oral inulin along with antidiabetes drugs may improve glycemic control in some patients with type 2 diabetes; however, the benefits of long-term use are unclear. Details: Two meta-analyses of clinical research in normal weight and obese patients with type 2 diabetes show that taking inulin 0.8-10 grams orally daily for 6-12 weeks reduces glycated hemoglobin (HbA1c) by 0.65% and fasting plasma glucose by 16 mg/dL when compared with control. Taking inulin also improved HOMA-IR, a measure of insulin resistance, when compared with control. Researchers did not evaluate the most effective dose of inulin; however, most studies used 8.4-10 grams daily (103198,105533). In females treated with metformin and glyburide, taking inulin 10 grams daily for 8 weeks reduces fasting blood glucose by 15 mg/dL and HbA1c by 1% when compared with placebo (93719). Population research in adults has also found that high dietary intake of inulin over 8 years of follow up is associated with a 6% lower risk of type 2 diabetes when compared with low dietary intake (110515). Inulin has also been studied in combination with other supplements. Preliminary clinical research in elderly patients with diabetes shows that drinking a milk powder product supplemented with inulin and resistant dextrin 30 grams before breakfast and 15 grams before dinner for 12 weeks decreases fasting plasma glucose by 17 mg/dL, HbA1c by 0.38%, postprandial glucose by 27 mg/dL, body weight by 0.8 kg, and systolic and diastolic blood pressure by 5 mmHg when compared with placebo (99843). Other clinical research in adults with type 2 diabetes shows that taking a specific combination product (Orafti Synergy1, BENEO GmbH), containing 50% inulin and 50% fructo-oligosaccharides, 8 grams orally twice daily for 6 weeks does not reduce body weight or caloric intake or increase satiety scores when compared with placebo (107934).
Obesity. Oral inulin might modestly improve short-term weight loss. Additional research is needed to determine the long-term effects of inulin on weight loss and weight maintenance in overweight or obese individuals. Details: Some clinical research in overweight and obese females with diabetes shows that taking inulin 10 grams daily for 8 weeks results in weight loss of 2.6 kg, compared with no weight loss in those taking placebo (93719). Preliminary clinical research in overweight or obese patients with prediabetes shows that taking a specific brand of inulin (Orafti Synergy 1, BENEO GmbH) 30 grams orally daily for 6 weeks reduces body weight by 0.4 kg, compared with a 0.4 kg increase in those in the control group (93721). Preliminary clinical research in adults with obesity shows that taking inulin 16 grams orally daily for 3 months moderately reduces body weight and body mass index (BMI) when compared with placebo. However, these effects were most prominent in subjects that also increased physical activity (110514). Additional preliminary clinical research in adults with overweight shows that adding 18 grams of inulin powder to green tea daily increases weight loss when compared with green tea alone. Over six weeks, individuals taking inulin lost 2 kg, compared with no weight loss in those taking green tea. Weight loss was maintained for at least 2 weeks (93726). Clinical trials in children show conflicting results. In children aged 7-12 years, a small clinical study shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy1, BENEO GmbH) 8 grams orally in water before one meal daily for 16 weeks decreases weight gain by 2.4-fold and attenuates an increase in BMI when compared with placebo (96847). However, other preliminary clinical research in children with obesity aged 7-15 years shows that taking inulin extract 13 grams orally daily for 6 months does not reduce body weight or BMI when compared with placebo (110598). However, other clinical research shows that taking inulin orally in combination with other ingredients might not improve weight loss. Combining inulin, chromium picolinate, capsicum, L-phenylalanine, and other nutrients with caloric reduction and exercise doesn't seem to reduce weight in moderately obese patients when compared to caloric reduction and exercise alone (7607). Another preliminary clinical trial shows that taking inulin 10 grams with maltodextrin 10 grams daily for 12 weeks does not reduce body weight or improve body composition when compared with placebo in adults with overweight or obesity following a calorie-restricted diet (103202). Preliminary clinical research in adults with obesity also shows that consuming a seafood-based dietary product fortified with inulin 1.7 grams, fish oil 370 mg (containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and bifidobacterium animalis daily for 12 weeks does not lower body weight, waist circumference, abdominal fat, serum cholesterol levels, or blood pressure when compared with placebo. However, consuming the product modestly improved some markers of insulin resistance (110600).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Alcohol use disorder. It is unclear if oral inulin is beneficial in patients with alcohol use disorder. Details: Preliminary clinical research in adults with alcohol use disorder who were recently admitted to the hospital shows that taking a specific inulin product (Fibruline, Cosucra) 4-16 grams orally daily for 17 days does not improve liver function tests when compared with placebo. Some liver function tests were also worse in those treated with inulin (110601).
Antibiotic-associated diarrhea. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children aged 6 months to 14 years receiving antibiotics for common infections shows that taking a combination of inulin and fructo-oligosaccharides, up to 5 grams daily depending on age, does not reduce the rate of antibiotic-associated diarrhea (93720).
Celiac disease. Small clinical studies suggest that patients with celiac disease who take oral inulin may have a lower risk of vitamin and mineral deficiency. Details: Preliminary clinical research in a small number of children and adolescents with vitamin and mineral malabsorption due to celiac disease shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy 1, BENEO GmbH) 10 grams daily for 3 months improves the absorption of vitamin D, vitamin E, and iron, but not vitamin A (99841,99842). Levels of 25-hydroxy vitamin D and vitamin E increased by 42% and 19%, respectively, compared with no significant improvements in those taking placebo (99842). Although taking inulin did not improve serum ferritin levels, it did decrease serum hepcidin concentrations by 61% when compared with baseline, while no significant improvement was reported with placebo. Hepcidin is a regulator of iron homeostasis, and increased levels are associated with iron-deficiency anemia (99841).
Child growth. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in healthy, exclusively formula-fed, infants less than 4 months of age shows that supplementing formula with 0.8 grams/dL of a specific combination product (Orafti Synergy1, Beneo-Orafti) containing 50% inulin and 50% fructo-oligosaccharide until 12 months of age does not improve markers of child growth, including body weight, length, and head circumference, when compared with placebo. The combination product was associated with a reduced duration of fever during infectious episodes, but not with a reduction in the number of infections. It is unclear if any potential effects are due to inulin, fructo-oligosaccharide, or the combination (107937).
Chronic kidney disease (CKD). It is unclear if oral inulin is beneficial in patients with CKD. Details: In adults with CKD, adding inulin 19 grams daily for 6 months to a low-protein diet reduces serum insulin, fasting plasma glucose, total serum cholesterol, triglycerides, and markers of systemic inflammation, while increasing serum high density lipoprotein (HDL) cholesterol, when compared with baseline (105534). However, it is unclear if similar changes occur with a low-protein diet alone, or if the rate of progression of CKD is reduced. Population research in adults has found that high dietary intake of inulin over 8 years of follow up is not associated with a lower risk of CKD when compared with low dietary intake (110515).
Hypercholesterolemia. It is unclear if oral inulin reduces cholesterol levels in patients with hypercholesterolemia. Details: Research in patients with hypercholesterolemia has shown mixed results, with some studies showing a small decrease and others showing no improvement in serum cholesterol levels (7604,8450,10412,10413,96849). A typical dose of inulin used is 6 grams orally three times daily for up to 6 weeks (10412). A meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that inulin reduces levels of low-density lipoprotein (LDL) cholesterol by approximately 5% (96849). Another meta-analysis of randomized clinical trials in the same population shows that taking inulin 1.5-30 grams daily for 2-12 weeks reduces LDL cholesterol levels by 7 mg/dL and increases high-density lipoprotein cholesterol levels by 2 mg/mL when compared with control. However, this meta-analysis also included data from patients treated with fructo-oligosaccharides instead of inulin (107940).
Hypertension. It is unclear if oral inulin is beneficial in patients with hypertension. Details: Population research in adults has found that high dietary intake of inulin over 8 years of follow up is associated with a 21% lower risk of hypertension when compared with low dietary intake (110515).
Hypertriglyceridemia. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: A meta-analysis of clinical trials in normal and moderately hyperlipidemic patients suggests that taking inulin-type fructans at an approximate average dose of 14 grams daily reduces triglyceride levels by about 15 mg/dL when compared with control (93737). However, other research, including a meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that taking inulin 1.5-30 grams daily for 2-12 weeks does not reduce triglyceride levels when compared with control. However, these negative studies are limited by small sample sizes and inclusion of data from patients treated with fructo-oligosaccharides instead of inulin (7604,107940).
Impaired glucose tolerance (prediabetes). Several small clinical studies suggest that oral inulin is not beneficial in patients with prediabetes. Details: Preliminary clinical research in adults with prediabetes shows that taking inulin 15 grams orally daily for 24 weeks does not improve fasting blood glucose, glycated hemoglobin (HbA1c), or lipid levels when compared with placebo. However, taking inulin modestly improved markers of insulin resistance (107938). Two other, small, clinical trials show that taking specific inulin products (Orafti Synergy 1, BENEO GmbH or Frutafit IQ, Sensus American) 10-30 grams daily for 6 weeks does not improve blood glucose, insulin resistance, glucose homeostasis, or insulin sensitivity when compared with placebo (93721,107936). However, these studies may have been inadequately powered to detect a difference between groups.
Iron deficiency anemia. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in young adult females with iron deficiency anemia shows that taking inulin 963 mg/kg and iron supplementation orally daily for 3 months modestly improves serum hemoglobin, hematocrit, and iron levels when compared with a control group consuming iron-fortified flour (110599).
Menopausal symptoms. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: Preliminary clinical research in adults experiencing menopause shows that consuming yogurt enriched with a specific inulin (Frutafit TEX, Sensus Company) 1.5% daily for 6 weeks moderately improves menopausal symptom scores, including depression, anxiety, and vasomotor symptoms, when compared with yogurt alone (107659).
Nonalcoholic fatty liver disease (NAFLD). Taking oral inulin alone does not seem to improve liver transaminase levels in patients with NAFLD. Details: Preliminary clinical research in patients with NAFLD shows that taking metronidazole 400 mg twice daily for one week plus inulin 4 grams twice daily for 12 weeks reduces levels of alanine aminotransferase and aspartate aminotransferase when compared with placebo. However, when inulin is taken without metronidazole, these measures are not improved (103200).
Polycystic ovary syndrome (PCOS). It is unclear if oral inulin is beneficial in patients with PCOS. Details: Preliminary clinical research in overweight or obese females with PCOS shows that taking specific products containing inulin (FrutaFit TEX, Sensus American) or inulin and fructo-oligosaccharides (FrutaFit IQ, Sensus American) 10 grams orally once daily for 12 weeks does not reduce systolic or diastolic blood pressure when compared with placebo. However, the validity of this study is limited by the inclusion of subjects with and without hypertension at baseline (107941). More evidence is needed to rate inulin for these uses.

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LECITHIN

LIKELY INEFFECTIVE

Alzheimer disease. Lecithin does not improve daily functioning in patients with Alzheimer disease. Details: In patients with Alzheimer disease, taking various types of lecithin, 1.2-45 grams daily for up to 6 months, alone or in combination with various conventional medications, does not improve cognitive function or other measures of disease progression (5149,5151,5152,5156,14817,14823,14825,14837,14838).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Age-related cognitive decline. It is unclear if oral lecithin can slow age-related cognitive decline. Details: A small clinical crossover study in healthy adults aged 64 years and older shows that taking lecithin 26 grams orally daily, alone or in combination with physostigmine, for 5 weeks does not seem to improve memory when compared with placebo (19204).
Anxiety. Although there is interest in using oral lecithin for anxiety, there is insufficient reliable information about the clinical effects of lecithin for this condition.
Atopic dermatitis (eczema). Although there is interest in using oral lecithin for atopic dermatitis, there is insufficient reliable information about the clinical effects of lecithin for this condition.
Bipolar disorder. It is unclear if oral lecithin is beneficial in patients with bipolar disorder. Details: A clinical study in six patients with mania shows that taking lecithin 10 mg three times daily improves symptoms of delusions, incoherent speech, and hallucinations when compared with placebo (14839).
Dry skin. Although there is interest in using topical lecithin for dry skin, there is insufficient reliable information about the clinical effects of lecithin for this condition.
Friedreich ataxia. Small clinical studies suggest that oral lecithin is not beneficial in people with Friedreich ataxia. Details: Preliminary clinical research shows that taking lecithin 25 grams orally daily for 1 month does not have any benefit in people with Friedreich ataxia (59298). Other preliminary clinical research shows that taking lecithin for a longer period of 6 months also does not improve performance (19211).
Hyperlipidemia. Although lecithin may lower cholesterol in healthy people, it does not seem to improve cholesterol levels in people with hyperlipidemia. Details: Some clinical research shows that taking lecithin 20-30 grams daily for up to 11 months decreases cholesterol in healthy people (5147,14820). However, other clinical research shows that lecithin has no effect on low-density lipoprotein cholesterol or total cholesterol levels in people with hyperlipidemia (5148,14820).
Parkinson disease. It is unclear if oral lecithin is beneficial in patients with Parkinson disease. Details: Preliminary clinical research in patients with Parkinson disease shows that taking lecithin 32 grams daily for 8 weeks does not improve symptoms when compared with placebo (19212).
Postoperative pain. It is unclear if oral lecithin is beneficial for reducing postoperative pain. Details: Preliminary clinical research shows that taking lecithin 20 grams prior to surgery increases choline levels, but does not reduce postoperative pain after gynecological surgery, when compared with placebo (91231).
Tardive dyskinesia. It is unclear if oral lecithin is beneficial in patients with tardive dyskinesia. Details: Two small clinical studies in patients with tardive dyskinesia shows that taking lecithin orally for 2 months, alone or in combination with lithium, does not improve symptoms when compared with placebo (14822,14824).
TPN-associated hepatic steatosis. It is unclear if oral lecithin is beneficial in patients with hepatic steatosis associated with long-term total parenteral nutrition (TPN). Details: A small clinical study in patients on long-term TPN with low choline levels suggests that taking lecithin 20 grams orally twice daily for 6 weeks reduces the degree of hepatic steatosis, compared with no significant changes in those taking placebo (5140).
Ulcerative colitis. Oral lecithin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a disease-specific medical food (Profermin, Nordisk Rebalance) containing lecithin, fermented oats, barley malt, and lactobacillus plantarum, as 250 mL twice daily for 24 weeks, decreases disease activity by over 56% when compared with baseline and leads to remission in 46% of patients with mild-to-moderate ulcerative colitis (91228). Other preliminary clinical research in this population shows that taking Profermin 250 mL twice daily for 8 weeks improves disease activity and remission rate when compared with another medical food (Fresubin Original, Fresenius Kabi) (90271). The effects of lecithin alone are unclear. More evidence is needed to rate lecithin for these uses.

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SODIUM

LIKELY EFFECTIVE

Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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WHEY PROTEIN (nondenatured Whey Protein concentrate, nondenatured Whey Protein isolate)

POSSIBLY EFFECTIVE

Athletic performance. Regular consumption of whey protein in conjunction with exercise may improve muscle strength and performance. However, inconsistent consumption of whey protein, as well as intake of whey protein without concomitant exercise, may not be beneficial. Details: Most clinical research shows that taking whey protein 1.2-1.5 grams/kg or 30-33 grams daily in combination with strength training for 6-21 weeks can increase lean body mass, strength, and muscle hypertrophy in healthy young adults (16728,16729,16748,46552,85765,85910,91806,96025,102173). Higher doses of whey protein, such as 46-77 grams daily, have also been shown to increase strength when combined with athletic training (98886,98888). Some clinical research shows that whey protein hydrolysate (Lacprodan HYDRO.365, Arla Food Ingridiens Group P/S) twice daily for 1 week may slightly improve running speed (91793). However, less frequent intake or lower doses of whey protein do not seem to be beneficial for muscle strength. Some clinical research in middle-aged males shows that taking whey protein 35 grams three times weekly with resistance training for 14 weeks does not improve strength or muscle mass when compared with placebo (46736,85893). A small clinical study in trained males shows that taking whey protein 25 grams daily has no effect on body mass or strength after 2 weeks of detraining and 4 weeks of retraining when compared with maltodextrin (96021). Also, consuming whey protein without concomitant exercise does not seem to improve body composition or strength. Some clinical research shows that whey protein does not improve muscle mass or strength in obese postmenopausal patients who are losing weight through diet without exercise (98889). Some research has compared whey protein to other types of protein. A meta-analysis of preliminary clinical research, as well as individual clinical studies, show that whey protein is similarly beneficial to soy, beef, chicken, and dairy (casein with whey) protein for improving muscle strength (85941,98871,98888,105591). However, the validity of these findings is limited by the small size and high heterogeneity of the studies.

POSSIBLY INEFFECTIVE

Chronic obstructive pulmonary disease (COPD). Oral whey protein does not seem to improve COPD symptoms. Details: Clinical research in adults with COPD shows that taking a specific whey protein supplement (ImuPower) 12 grams twice daily for 6 weeks can improve shortness of breath, but not lung function, exercise tolerance, or quality of life, when compared with placebo (86302). Other clinical research shows that taking a pressurized whey protein supplement 20 grams daily for 16 weeks, in combination with strength training for weeks 8-16, does not improve exercise tolerance, lung function, or muscle function when compared with placebo (86025).
Osteoporosis. Oral whey protein does not seem to improve bone mineral density in older adults. Details: Clinical research shows that taking whey protein 30-45 grams daily for up to 2 years does not improve bone density when compared with a low-protein placebo in postmenopausal patients and males over 70 years of age (86074,91796). Taking whey protein 20-60 grams daily for 36 weeks also does not improve bone density when compared with an isoenergetic placebo in overweight or obese adults undergoing an exercise program (96027). The effect of whey protein in patients with osteoporosis has not been evaluated.

INSUFFICIENT RELIABLE EVIDENCE to RATE

Age-related cognitive decline. It is unclear if oral whey protein is beneficial for age-related cognitive impairment. Details: Preliminary clinical research in older adults with subjective cognitive decline shows that taking whey peptide 1 gram for 12 weeks does not improve memory, executive functioning, or attention when compared with placebo. However, in a subgroup of patients with high levels of fatigue, whey peptide modestly improved memory (98885).
Asthma. It is unclear if oral whey protein is beneficial in children with asthma. Details: A very small clinical study in children with asthma shows that taking a specific type of whey protein (HMS 90, Immunotec Inc.) 20 grams daily for 30 days does not improve lung function when compared to baseline (85833). The validity of this finding is limited by the lack of a comparator group.
Atopic dermatitis (eczema). It is unclear if consuming infant formula containing whey protein reduces the risk of developing eczema. Details: A high-quality meta-analysis of small clinical studies shows that use of infant formula containing hydrolyzed whey protein for 4-6 months is no better than standard milk formula for reducing the risk of eczema (105585). This is in contrast to older meta-analyses that found benefit after consumption of fully or partially hydrolyzed whey protein (85987,86007,86048). However, these older publications had notable conflicts of interest and did not include small negative studies (105585). In 2011, the US Food and Drug Administration (FDA) allowed a qualified health claim in healthy infants with a family history of allergy who are not solely breastfed. It stated that feeding a formula of 100% partially hydrolyzed whey protein instead of formula containing intact cow's milk proteins from birth up to 4 months of age may reduce the risk of atopic dermatitis throughout 1-3 years of age. However, the FDA has concluded that there is very little scientific evidence to support this claim (102311).
Atopic disease. It is unclear if consuming infant formula containing whey protein reduces the risk of developing atopic disease. Details: A high-quality meta-analysis of small clinical studies shows that use of infant formula containing hydrolyzed whey protein for 4-6 months is no different than standard milk formula for reducing the risk of atopic disease. However, there was a non-significant trend to reduced risk in the hydrolyzed whey protein group (105585). This finding conflicts with older meta-analyses which found benefit with hydrolyzed whey protein formula (85987,86007). However, these older publications had notable conflicts of interest and did not include small negative studies (105585).
Cystic fibrosis. It is unclear if oral whey protein is beneficial for children or adults with cystic fibrosis. Details: A small clinical study in patients with cystic fibrosis shows that taking pressurized whey protein, 20 grams in children and 40 grams in adults, daily for 28 days, improves lung function in children, but not adults, when compared with baseline (85995). The validity of this finding is limited by the lack of a comparator group.
Diabetes. It is unclear if oral whey protein is beneficial for improving glycemic control in people with type 2 diabetes. Details: A small clinical study in patients with well-controlled diabetes shows that consuming a 220 kcal drink containing whey protein concentrate 50 grams (Beit Haemek Advanced Technologies, Beit Haemek) before a meal lowers blood glucose levels by 28% and increases insulin levels in the first 3 hours after a meal when compared with drinking water (91795). However, whey protein does not seem to have long-term benefit on glycemic control when added to an exercise regimen. Another small clinical study in middle-aged males with type 2 diabetes shows that adding 20 grams of whey protein daily for 10 weeks to high-intensity mixed-mode interval training (MMIT) does not further improve glycemic control or body composition when compared to MMIT with placebo (98883).
Exercise-induced asthma. It is unclear if oral whey protein is beneficial for exercise-induced asthma. Details: A small clinical study in patients with exercise-induced asthma shows that taking whey protein 30 grams daily for 10 days improves lung function when compared to baseline (85791). The validity of this finding is limited by the lack of a comparator group.
Exercise-induced muscle damage. It is unclear if oral whey protein is beneficial for attenuating exercise-induced muscle damage; evidence is conflicting. Details: A meta-analysis of small heterogeneous clinical studies in trained and untrained adults shows that supplementation with a median dose of whey protein 25 grams (range 20-120 grams) given after and/or before exercise modestly improves muscle recovery measured over 3 days when compared with control (98881). Individual studies included in the analysis used whey protein 1.5 grams/kg daily for up to 2 weeks (86044), and whey protein isolate or whey protein hydrolysate (NatraPro or NatraBoost XR, MG Nutritionals) 25 grams three times in 24 hours (85915). Other small studies have not found benefit, but it is unclear if they were adequately powered. One small clinical study in healthy untrained males shows that taking whey protein 36.6 grams daily, starting 7 days before and continuing until 4 days after arm exercise, does not prevent muscle soreness over 5 days or attenuate reductions in strength (96024). Another small study in untrained healthy males shows that taking whey protein isolate (biPro, Eden Prairie) 0.3 grams/kg three times daily for 5 days does not reduce self-reported delayed onset muscle soreness, but may reduce creatine kinase, a biomarker of muscle damage, when compared with water (104758). Whey protein may not be beneficial for recovery from exercise in trained athletes. Small clinical studies show that consuming a whey protein beverage before or after exercise does not improve muscle recovery for trained adult and adolescent athletes when compared with a carbohydrate or non-caloric control (86303,91799,105592).
Hepatitis. It is unclear if oral whey protein is beneficial for hepatitis. Details: A small clinical study in patients with chronic hepatitis B shows that taking a specific type of whey protein (Immunocal) 12 grams twice daily for 12 weeks can reduce liver transaminase levels and can increase glutathione (GSH) levels when compared with baseline. However, whey protein supplementation does not seem to improve liver function in patients with chronic hepatitis C (85687). The validity of these findings is limited by the lack of a comparator group.
HIV/AIDS. It is unclear if oral whey protein is beneficial for improving immune function in children with HIV/AIDS. Details: One small clinical study in children with rapidly progressive HIV infection shows that taking whey protein at levels corresponding to 20% to 50% of total required protein for 4 months does not affect CD4 or CD8 cell count or the ratio of CD4+/CD8+ when compared with baseline. However, the occurrence of acute co-infections might be reduced with whey protein supplementation when compared with control (85781).
HIV/AIDS-related wasting. Although oral whey is an adequate source of protein, it is unclear if it is better than other protein sources for reducing HIV/AIDs-related wasting. Details: A small open-label clinical study in malnourished patients with HIV shows that taking whey protein (dose unspecified) daily for 14 weeks increases muscle and fat mass when compared with baseline (85693). The validity of these findings is limited by the lack of a comparator group. Another small study in patients with HIV, stable weight, and a history of unintentional weight loss shows that taking whey protein 40 grams daily for 12 weeks does not affect weight or muscle mass when compared with taking an isocaloric control (85921). These study findings are limited because they cannot be generalized to patients with active weight loss or wasting. Another limitation is the higher dropout rate in the whey protein group due to gastrointestinal adverse events.
Hyperlipidemia. It is unclear if oral whey protein is beneficial for lowering cholesterol levels. Details: A very small clinical study in overweight males with hyperlipidemia shows that taking whey protein 26.6 grams daily while participating in a resistance training program for 12 weeks reduces total cholesterol levels when compared with baseline but not when compared with placebo (85941). A meta-analysis of small heterogeneous clinical studies in healthy adults, as well as those with obesity and/or mild hypertension, shows that consuming whey protein alone or with other interventions seems to reduce lipid levels when compared with control (105586). However, most included studies were in patients without hyperlipidemia; it is unclear if whey protein is beneficial in patients with hyperlipidemia. Furthermore, these findings are limited by the variability in whey protein dosing, study duration, and patient population.
Hypertension. It is unclear if oral whey protein reduces blood pressure. Details: Preliminary clinical research shows that drinking a beverage containing whey protein 2.6 grams daily for 12 weeks does not lower blood pressure in patients with mild hypertension when compared with placebo (85835). Also, taking whey protein 28 grams twice daily in water for 8 weeks reduces 24-hour systolic and diastolic blood pressure by 2.9 mm Hg and 2 mmHg, respectively, when compared with maltodextrin or casein in adults with mild hypertension and prehypertension. There were also improvements in endothelial function (96019).
Mitochondrial myopathies. It is unclear if oral whey protein improves symptoms in patients with mitochondrial myopathies. Details: A small clinical study in individuals with mitochondrial diseases shows that taking a whey protein supplement 10 grams daily for one month does not improve muscle strength or quality of life when compared with placebo (85984).
Nonalcoholic steatohepatitis (NASH). It is unclear if oral whey protein improves NASH. Details: A small clinical study in patients with untreated NASH shows that taking whey protein 20 grams daily for 12 weeks can reduce liver function tests, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and reduce hepatic macrovesicular steatosis when compared with baseline (85961). The validity of these findings is limited by the lack of a comparator group.
Obesity. It is unclear if oral whey protein is beneficial for weight loss when used without dietary modifications. Adding whey protein to a calorie-restricted diet or an exercise regimen does not seem to improve weight loss. Details: Most research in overweight and obese individuals shows that taking whey protein along with a low-calorie diet and/or in addition to an exercise program does not further increase weight loss when compared with the low-calorie diet or exercise alone (85897,86069,86130,91794,91798,91802,96027,102172). However, a small clinical study in patients who have regained weight after bariatric surgery shows that following a low-calorie diet and taking whey protein 0.5 grams/kg daily for 16 weeks reduces body weight by about 2 kg and fat mass by about 3 kg when compared with following a low-calorie diet alone (96022). When whey protein is taken without diet modifications, studies have yielded conflicting results. One small clinical study in overweight and obese adults shows that taking whey protein isolate 27 grams twice daily for 12 weeks does not reduce body weight when compared with a glucose control (86011). However, another small clinical study in overweight and obese adults shows that taking whey protein concentrate 52 grams daily for 23 weeks reduces weight by 1.8 kg and fat by 2.4 kg when compared with a carbohydrate control, but is no better than taking soy protein isolate 52 grams (86077). In contrast, a small clinical study in overweight males shows that taking whey protein concentrate 65 grams before lunch daily for 12 weeks decreases calorie intake and reduces weight by about 1 kg when compared with taking soy protein isolate 60 grams (91801). In contrast to adults, supplementation with whey protein might increase weight in adolescents. A clinical study in overweight adolescents shows that consuming 1 liter of a milk-based whey protein drink daily for 12 weeks increases weight and body mass index when compared with a water control (86144).
Parkinson disease. It is unclear if oral whey protein improves symptoms of Parkinson disease. Details: Clinical research in a small group of patients shows that taking a specific type of whey protein isolate (HMS 90/Immunocal) 10 grams twice daily for 6 months does not improve symptoms of Parkinson disease when compared with placebo (96026). However, this study may have been inadequately powered to detect a difference between groups.
Polycystic ovary syndrome (PCOS). It is unclear if oral whey protein improves symptoms and metabolic effects of PCOS. Details: One small clinical study in patients with PCOS shows that taking 240 kcal as a nutritional supplement containing pure whey protein 96% daily, in addition to a calorie-restricted diet for 2 months, reduces body weight, fat mass, and cholesterol and apolipoprotein B levels when compared with a simple sugar control supplement. However, the whey protein supplement does not improve glucose or insulin levels, and seems to decrease high-density lipoprotein (HDL) cholesterol levels (85912). The validity of this study is limited by its small size and a significant dropout rate.
Polymyalgia rheumatica. It is unclear if oral whey protein improves muscle function in patients with polymyalgia rheumatica. Details: A small clinical study in patients with polymyalgia rheumatica shows that taking a whey protein-enriched dairy product twice daily for 8 weeks does not improve lower limb muscle function, walking speed, chair stand test performance, peak jump power, or peak jump force when compared with a regular dairy product (Play, Valio Ltd.) (86075).
Psoriasis. It is unclear if oral whey protein improves psoriasis. Details: A small clinical study in patients with stable psoriasis shows that taking a specific whey protein extract product (Dermylex, Advitech, Inc.) 5 grams daily for 8 weeks modestly decreases symptom severity when compared with placebo (85885).
Sarcopenia. Research on the use of oral whey protein in older adults with sarcopenia is conflicting. Details: Small clinical studies in trained older females show that consuming whey protein 35 grams three times weekly for 12 weeks, either before or after resistance training, modestly increases skeletal muscle mass, strength, and functional capacity when compared with resistance training and insufficient protein intake (98887,98890). Research on the use of whey supplementation without exercise is conflicting. A small clinical study in older adults with low muscle mass living in China shows that taking whey, or a whey-soy protein blend, 16 grams daily for 6 months slightly attenuates muscle loss when compared with no intervention (105603). However, a clinical study in healthy, active older adults living in Denmark shows that taking whey protein hydrolysate 20 grams twice daily does not increase muscle size or strength when compared with a carbohydrate control (105593). This finding may not be generalizable to frail adults or those with existing sarcopenia. Whey protein with or without exercise has shown benefit when used in combination with other nutrients. Specifically, whey protein 60 grams has been used with creatine 5 grams, calcium 800 mg, vitamin D 1000 IU, and omega-3 fatty acids 3 grams (Infinit Nutrition) for 6 weeks (96016). A beverage with leucine-enriched whey protein 20 grams has been used in combination with vitamin D 800 IU (Nutricia Advanced Medical Nutrition) daily for 6 weeks (96017). Another beverage containing whey protein 20 grams and vitamin D 800 IU has been used daily for 6 months (98882).
Sepsis. It is unclear if oral whey protein is beneficial in children with sepsis. Details: A very small clinical study in long-term intensive care pediatric patients shows that taking a specific whey protein supplement (Beneprotein) 0.3 grams/kg daily for up to 28 days has a similar effect on the time to onset and the rate of hospital-acquired infection or sepsis when compared with taking a combination of zinc, selenium, glutamine, and metoclopramide. It is not clear how these results compare to patients receiving no supplementation (86095). More evidence is needed to rate whey protein for these uses.

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Safety view details

Below is general information about the safety of the known ingredients contained in the product Whey Pro Complete. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BOVINE COLOSTRUM (Colostrum)

LIKELY SAFE ...when used orally and appropriately. There are no reports of significant toxicity in multiple human trials (4901,4903,4904,4905,4906,4907,4908,4909,36980,36988) (36992,36995,36998,37000,92412,92413,92415,101799,111136,111138) (111139,114817). However, bovine colostrum is derived from animals, and there is some concern about contamination with diseased animal parts (1825). So far, there are no reports of disease transmission to humans due to use of contaminated bovine colostrum.

POSSIBLY SAFE ...when used rectally and appropriately, short-term. Bovine colostrum has been used with apparent safety when administered as a 10% enema twice weekly for up to 4 weeks (9730). ...when used intravaginally and appropriately, short-term. Bovine colostrum has been used with apparent safety when administered vaginally as a tablet twice weekly for up to 6 months, as a 1% cream once daily for up to 15 days, or as a gel containing 2.3% bovine colostrum daily for 12 weeks (92424,98819,101794). There is insufficient reliable information available about the safety of bovine colostrum when used topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Bovine colostrum has been used with apparent safety in children for 1-3 months (92420,95924,101797,114819). There is insufficient reliable information available about the safety of long-term use of bovine colostrum in children.

CHILDREN: POSSIBLY UNSAFE
when used enterally in very preterm infants in the first few weeks of life. Enterally, bovine colostrum added to breastmilk for very preterm infant feeding in the first 14 days of life has been associated with a higher rate of periventricular leukomalacia when compared with preterm formula added to breastmilk in one clinical trial (114816). Orally, the addition of bovine colostrum to breastmilk for very preterm infant feeding resulted in infants requiring more calcium and phosphate supplementation to maintain acceptable blood levels when compared with conventional fortifier in one clinical trial (114822).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about BOVINE COLOSTRUM)

CALCIUM

LIKELY SAFE ...when used orally or intravenously and appropriately. Calcium is safe when used in appropriate doses (7555,12928,12946,95817). However, excessive doses should be avoided. The Institute of Medicine sets the daily tolerable upper intake level (UL) for calcium according to age as follows: Age 0-6 months, 1000 mg; 6-12 months, 1500 mg; 1-8 years, 2500 mg; 9-18 years, 3000 mg; 19-50 years, 2500 mg; 51+ years, 2000 mg (17506). Doses over these levels can increase the risk of side effects such as kidney stone, hypercalciuria, hypercalcemia, and milk-alkali syndrome. There has also been concern that calcium intake may be associated with an increased risk of cardiovascular disease (CVD) and coronary heart disease (CHD), including myocardial infarction (MI). Some clinical research suggests that calcium intake, often in amounts over the recommended daily intake level of 1000-1300 mg daily for adults, is associated with an increased risk of CVD, CHD, and MI (16118,17482,91350,107233). However, these studies, particularly meta-analyses, have been criticized for excluding trials in which calcium was administered with vitamin D (94137). Other clinical studies suggest that, when combined with vitamin D supplementation, calcium supplementation is not associated with an increased risk of CVD, CHD, or MI (93533,107231). Other analyses report conflicting results and have not shown that calcium intake affects the risk of CVD, CHD, or MI (92994,93533,97308,107231). Advise patients not to consume more than the recommended daily intake of 1000-1200 mg per day, to consider total calcium intake from both dietary and supplemental sources (17484), and to combine calcium supplementation with vitamin D supplementation (93533).

POSSIBLY UNSAFE ...when used orally in excessive doses. The National Academy of Medicine sets the daily tolerable upper intake level (UL) for calcium according to age as follows: 19-50 years, 2500 mg; 51 years and older, 2000 mg (17506). Doses over these levels can increase the risk of side effects such as kidney stones, hypercalciuria, hypercalcemia, and milk-alkali syndrome. There has also been concern that calcium intake may be associated with an increased risk of cardiovascular disease (CVD) and coronary heart disease (CHD), including myocardial infarction (MI). Some clinical research suggests that calcium intake, often in amounts over the recommended daily intake level of 1000-1300 mg daily for adults, is associated with an increased risk of CVD, CHD, and MI (16118,17482,91350,107233). However, these studies, particularly meta-analyses, have been criticized for excluding trials in which calcium was administered with vitamin D (94137). Other clinical studies suggest that, when combined with vitamin D supplementation, calcium supplementation is not associated with an increased risk of CVD, CHD, or MI (93533,107231). Other analyses report conflicting results and have not shown that calcium intake affects the risk of CVD, CHD, or MI (92994,93533,97308,107231). Advise patients to not consume more than the recommended daily intake of 1000-1200 mg per day, to consider total calcium intake from both dietary and supplemental sources (17484), and to combine calcium supplementation with vitamin D supplementation (93533).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Calcium is safe when used in appropriate doses (17506).

CHILDREN: POSSIBLY UNSAFE
when used orally in excessive doses. The Institute of Medicine sets the daily tolerable upper intake level (UL) for calcium according to age as follows: 0-6 months, 1000 mg; 6-12 months, 1500 mg; 1-8 years, 2500 mg; 9-18 years, 3000 mg (17506). Doses over these levels can increase the risk of side effects such as kidney stones, hypercalciuria, hypercalcemia, and milk-alkali syndrome.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately (945,1586,3263,3264,17506). The World Health Organization (WHO) recommends prescribing oral calcium supplementation 1.5-2 grams daily during pregnancy to those with low dietary calcium intake to prevent pre-eclampsia (97347).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in excessive doses. The Institute of Medicine sets the same daily tolerable upper intake level (UL) for calcium according to age independent of pregnancy status: 9-18 years, 3000 mg; 19-50 years, 2500 mg (17506). Doses over these amounts might increase the risk of neonatal hypocalcemia-induced seizures possibly caused by transient neonatal hypoparathyroidism in the setting of excessive calcium supplementation during pregnancy, especially during the third trimester. Neonatal hypocalcemia is a risk factor for neonatal seizures (97345).

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INULIN

LIKELY SAFE ...when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

POSSIBLY SAFE ...when used orally and appropriately in supplemental doses, short-term. Doses of 8-18 grams daily have been used safely for up to 24 weeks (7604,7605,7606,7607,8451,93716,93719,93726,103200,107936,107935,107938). Also, 20 grams daily has been used with apparent safety for up to 3 weeks (96836,96850). There is insufficient reliable information available about the safety of inulin when used long-term.

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in supplemental doses, short-term. Clinical studies have used doses of 3-6 grams daily for 10 days in children 3-6 years of age and 5-13 grams daily for up to 6 months in children 7-15 years of age with apparent safety (96847,110598,110602). ...when used in infant formula. A formula containing chicory fructans (Orafti Synergy1, BENEO GmbH), approximately 50% of which were inulin, has been used with apparent safety in infants for 8-12 months (93717,107937).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (93728). There is insufficient reliable information available about using inulin in medicinal amounts during pregnancy or lactation; avoid use.

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LECITHIN

LIKELY SAFE ...when used orally in amounts commonly found in foods. Lecithin has Generally Recognized As Safe (GRAS) status in the US (2619,105544). ...when used orally and appropriately in medicinal amounts. Lecithin has been used safely in doses of up to 30 grams daily for up to 6 weeks (5140,5149,5152,5156,14817,14822,14838,19212). ...when used topically (4914).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts. Lecithin has Generally Recognized As Safe (GRAS) status in the US (105544). There is insufficient reliable information available about the safety of medicinal amounts of lecithin during pregnancy or lactation; avoid using.

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SODIUM

LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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WHEY PROTEIN (nondenatured Whey Protein concentrate, nondenatured Whey Protein isolate)

LIKELY SAFE ...when used orally and appropriately. Whey protein up to 30 grams has been safely used in clinical trials for up to 6 months (4930,16728,16729,105587).

CHILDREN: LIKELY SAFE
when used orally and appropriately as a dietary protein in food or infant formula. Hydrolyzed whey protein-based formula has been safely used in infants for up to 6 months in clinical trials (4927,105585,105594).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about WHEY PROTEIN)

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Interactions with Drugs view details

Below is general information about the interactions of the known ingredients contained in the product Whey Pro Complete. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BOVINE COLOSTRUM (Colostrum)

None known.

(Read more about BOVINE COLOSTRUM)

CALCIUM

ALUMINUM

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Calcium citrate might increase aluminum absorption and toxicity. Other types of calcium do not increase aluminum absorption.

Details

Calcium citrate can increase the absorption of aluminum when taken with aluminum hydroxide. The increase in aluminum levels may become toxic, particularly in individuals with kidney disease (21631). However, the effect of calcium citrate on aluminum absorption is due to the citrate anion rather than calcium cation. Calcium acetate does not appear to increase aluminum absorption (93006).

BISPHOSPHONATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = C

Calcium reduces the absorption of bisphosphonates.

Details

Advise patients to take bisphosphonates at least 30 minutes before calcium, but preferably at a different time of day. Calcium supplements decrease absorption of bisphosphonates (12937).

CALCIPOTRIENE (Dovonex)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Taking calcipotriene with calcium might increase the risk for hypercalcemia.

Details

Calcipotriene is a vitamin D analog used topically for psoriasis. It can be absorbed in sufficient amounts to cause systemic effects, including hypercalcemia (12938). Theoretically, combining calcipotriene with calcium supplements might increase the risk of hypercalcemia.

CALCIUM CHANNEL BLOCKERS

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = D

Intravenous calcium may decrease the effects of calcium channel blockers; oral calcium is unlikely to have this effect.

Details

Intravenous calcium is used to decrease the effects of calcium channel blockers in the management of overdose. Intravenous calcium gluconate has been used before intravenous verapamil (Isoptin) to prevent or reduce the hypotensive effects without affecting the antiarrhythmic effects (6124). But there is no evidence that dietary or supplemental calcium when taken orally interacts with calcium channel blockers (12939,12947).

CEFTRIAXONE (Rocephin)

Interaction Rating = Major Do not take this combination.

Severity = High • Occurrence = Probable • Level of Evidence = D

Co-administration of intravenous calcium and ceftriaxone can result in precipitation of a ceftriaxone-calcium salt in the lungs and kidneys.

Details

Avoid administering intravenous calcium in any form, such as parenteral nutrition or Lactated Ringers, within 48 hours of intravenous ceftriaxone. Case reports in neonates show that administering intravenous ceftriaxone and calcium can result in precipitation of a ceftriaxone-calcium salt in the lungs and kidneys. In several cases, neonates have died as a result of this interaction (15794,21632). So far there are no reports in adults; however, there is still concern that this interaction might occur in adults.

DIGOXIN (Lanoxin)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Using intravenous calcium with digoxin might increase the risk of fatal cardiac arrhythmias.

Details

Hypercalcemia increases the risk of fatal cardiac arrhythmias with digoxin (12940). However, one retrospective analysis of clinical data suggests that intravenous calcium does not increase the risk of dysrhythmias or mortality in patients receiving digoxin (38960).

DILTIAZEM (Cardizem, others)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, calcium may reduce the therapeutic effects of diltiazem.

Details

Hypercalcemia can reduce the effectiveness of verapamil in atrial fibrillation (10574). Theoretically, calcium might increase this risk of hypercalcemia and reduce the effectiveness of diltiazem.

DOLUTEGRAVIR (Tivicay)

Interaction Rating = Major Do not take this combination.

Severity = High • Occurrence = Probable • Level of Evidence = B

Calcium seems to reduce levels of dolutegravir.

Details

Advise patients to take dolutegravir either 2 hours before or 6 hours after taking calcium supplements. Pharmacokinetic research suggests that taking calcium carbonate 1200 mg concomitantly with dolutegravir 50 mg reduces plasma levels of dolutegravir by almost 40%. Calcium appears to decrease levels of dolutegravir through chelation (93578).

ELVITEGRAVIR (Vitekta)

Interaction Rating = Major Do not take this combination.

Severity = High • Occurrence = Probable • Level of Evidence = B

Calcium seems to reduce levels of elvitegravir.

Details

Advise patients to take elvitegravir either 2 hours before or 2 hours after taking calcium supplements. Pharmacokinetic research suggests that taking calcium along with elvitegravir can reduce blood levels of elvitegravir through chelation (94166).

LEVOTHYROXINE (Synthroid, others)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = B

Calcium seems to reduce the absorption and effectiveness of levothyroxine.

Details

Advise patients to take levothyroxine and calcium supplements at least 4 hours apart. Calcium reduces levothyroxine absorption, probably by forming insoluble complexes (5082). Calcium carbonate supplements reduce effectiveness of levothyroxine in patients with hypothyroidism (5081,5082,6137).

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, concomitant use of calcium and lithium may increase this risk of hypercalcemia.

Details

Clinical research suggests that long-term use of lithium may cause hypercalcemia in 10% to 60% of patients (38953). Theoretically, concomitant use of lithium and calcium supplements may further increase this risk.

QUINOLONE ANTIBIOTICS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = B

Calcium seems to reduce the absorption of quinolone antibiotics.

Details

Advise patients to take oral quinolones at least 2 hours before or 4-6 hours after calcium supplements or calcium-fortified foods. Taking calcium at the same time as oral quinolones can reduce quinolone absorption. Calcium binds to quinolones in the gut (4412,10339,21638,38570).

RALTEGRAVIR (Isentress)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = B

Calcium may reduce levels of raltegravir.

Details

Pharmacokinetic research shows that taking a single dose of calcium carbonate 3000 mg along with raltegravir 400 mg twice daily modestly decreases the mean area under the curve of raltegravir, but the decrease does not necessitate a dose adjustment of raltegravir (94164). However, a case of elevated HIV-1 RNA levels and documented resistance to raltegravir has been reported for a patient taking calcium carbonate 1 gram three times daily plus vitamin D3 (cholecalciferol) 400 IU three times daily in combination with raltegravir 400 mg twice daily for 11 months. It is thought that calcium reduced raltegravir levels by chelation, leading to treatment failure (94165).

SOTALOL (Betapace)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Calcium seems to reduce the absorption of sotalol.

Details

Advise patients to separate doses by at least 2 hours before or 4-6 hours after calcium. Calcium appears to reduce the absorption of sotalol, probably by forming insoluble complexes (10018).

TETRACYCLINE ANTIBIOTICS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = C

Calcium seems to reduce the absorption of tetracycline antibiotics.

Details

Advise patients to take oral tetracyclines at least 2 hours before, or 4-6 hours after calcium supplements. Taking calcium at the same time as oral tetracyclines can reduce tetracycline absorption. Calcium binds to tetracyclines in the gut (1843).

THIAZIDE DIURETICS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = C

Taking calcium along with thiazides might increase the risk of hypercalcemia and renal failure.

Details

Thiazides reduce calcium excretion by the kidneys (1902). Using thiazides along with moderately large amounts of calcium carbonate increases the risk of milk-alkali syndrome (hypercalcemia, metabolic alkalosis, renal failure). Patients may need to have their serum calcium levels and/or parathyroid function monitored regularly.

VERAPAMIL (Calan, others)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, calcium may reduce the therapeutic effects of verapamil.

Details

Hypercalcemia can reduce the effectiveness of verapamil in atrial fibrillation (10574). Theoretically, use of calcium supplements may increase this risk of hypercalcemia and reduce the effectiveness of verapamil.

(Read more about CALCIUM)

INULIN

ANTIDIABETES DRUGS

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = D

Theoretically, inulin might increase the risk of hypoglycemia with antidiabetes drugs.

Details

Some clinical research shows that inulin improves glycemic control in patients with diabetes; however, it is unclear if it has hypoglycemic effects (93719,99843,103198).

(Read more about INULIN)

LECITHIN

None known.

(Read more about LECITHIN)

SODIUM

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = A

Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.

Details

High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.

Details

Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = B

Altering dietary intake of sodium might alter the levels and clinical effects of lithium.

Details

High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.

Details

The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = C

Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.

Details

Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

(Read more about SODIUM)

WHEY PROTEIN (nondenatured Whey Protein concentrate, nondenatured Whey Protein isolate)

BISPHOSPHONATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, whey protein might reduce the absorption of bisphosphonates.

Details

Whey protein contains minerals such as calcium that bind bisphosphonates in the gut (9,12937). Advise patients to take bisphosphonates at least 30 minutes before whey protein, but preferably at a different time of day.

LEVODOPA

Interaction Rating = Major Do not take this combination.

Severity = High • Occurrence = Probable • Level of Evidence = D

Theoretically, whey protein might decrease levodopa absorption.

Details

Small clinical studies show that concomitant ingestion of protein or high doses of leucine or isoleucine (100 mg/kg) and levodopa can exacerbate tremor, rigidity, and the "on-off" syndrome in patients with Parkinson disease (3291,3292,3293,3294,4944).

QUINOLONE ANTIBIOTICS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, whey protein might decrease quinolone absorption.

Details

Whey protein contains minerals, such as calcium, that can bind to quinolones in the gut (9,10339). To avoid this interaction, advise patients to take oral quinolones at least 2 hours before or 4-6 hours after whey protein.

TETRACYCLINE ANTIBIOTICS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, whey protein might decrease tetracycline absorption.

Details

Whey protein contains minerals, such as calcium, that bind to tetracyclines in the gut (9,1843). To avoid this interaction, advise patients to take oral tetracyclines at least 2 hours before or 4-6 hours after whey protein.

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Adverse Effects view details

Report an Adverse Reaction to Whey Pro Complete

Below is general information about the adverse effects of the known ingredients contained in the product Whey Pro Complete. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BOVINE COLOSTRUM (Colostrum)

General ...Orally, bovine colostrum is well tolerated.

Endocrine ...Enterally, the addition of bovine colostrum to breastmilk for very preterm infant feeding resulted in infants requiring more calcium and phosphate supplementation to maintain acceptable blood levels when compared with conventional fortifier in one clinical trial (114822).

Gastrointestinal ...Orally, bovine colostrum has caused nausea and vomiting in an individual with HIV-related cryptosporidiosis (4905). In clinical trials of bovine colostrum, bloating, nausea, diarrhea, and unsettled stomach have been reported as mild in nature by a few patients (92414,101792) with a similar rate of occurrence as those taking a whey-based control (114819).

Hematologic ...Orally, bovine colostrum has caused decreased serum hematocrit in HIV patients treated for infectious diarrhea (4905).

Hepatic ...Orally, bovine colostrum has caused elevated liver function tests in HIV patients treated for infectious diarrhea (4905).

Immunologic ...Topically, there is a case report of anaphylaxis, urticaria, and itching related to bovine colostrum (101793).

Neurologic/CNS ...Enterally , bovine colostrum has been associated with increased risk of periventricular leukomalacia in very preterm infants. Specifically, in a large, multi-center, clinical study conducted in 7 neonatal intensive care units in China, 5 cases of periventricular leukomalacia (PVL), diagnosed with magnetic resonance imaging, were reported among the 155 infants fed bovine colostrum supplemented breastmilk until postnatal day 14, while no cases were reported among the 181 infants receiving preterm formula supplemented breastmilk. Three of the 5 infants with PVL were fed small volumes of bovine colostrum (less than 10 mL/kg daily) while 2 were fed larger volumes of bovine colostrum (18-35 mL/kg daily). in addition to preterm formula (114816).

Renal ...Enterally, bovine colostrum added to breastmilk for infant feeding until postnatal day 14 among very preterm infants has been associated with higher blood urea nitrogen levels by about 3 mg/dL when compared with preterm formula added to breastmilk (114816).

Other ...Theoretical adverse effects to bovine colostrum include an allergic reaction in individuals allergic to bovine milk products. There is also some concern that bovine colostrum that is obtained from cows in countries where bovine spongiform encephalitis (BSE) has been reported might be unsafe, however, there is no research indicating that colostrum can be contaminated with the BSE-causing prion. Countries where BSE has been reported include Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland, Switzerland, Oman, and Belgium (1825). Until more is known, tell patients to avoid these products unless country of origin can be determined. Patients should avoid products that are produced in countries where BSE has been found.

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CALCIUM

General ...Orally and intravenously, calcium is well-tolerated when used appropriately.
Most Common Adverse Effects:
Orally: Belching, constipation, diarrhea, flatulence, and stomach upset.
Serious Adverse Effects (Rare):
Orally: Case reports have raised concerns about calciphylaxis and kidney stones.

Cardiovascular ...There has been concern that calcium intake may be associated with an increased risk of cardiovascular disease (CVD) and coronary heart disease (CHD), including myocardial infarction (MI). Some clinical research suggests that calcium intake, often in amounts over the recommended daily intake level of 1000-1300 mg daily for adults, is associated with an increased risk of CVD, CHD, and MI (16118,17482,91350,107233). However, these results, particularly meta-analyses, have been criticized for excluding trials in which calcium was administered with vitamin D (94137). Many of these trials also only included postmenopausal females. Other analyses report conflicting results, and have not shown that calcium intake affects the risk of CVD, CHD, or MI (92994,93533,97308,107231). Reasons for these discrepancies are not entirely clear. It may relate to whether calcium is taken as monotherapy or in combination with vitamin D. When taken with vitamin D, which is commonly recommended, calcium supplementation does not appear to be associated with an increased risk of CVD, CHD, or MI (93533,107231). Also, the association between calcium supplementation and CVD, CHD, or MI risk may be influenced by the amount of calcium consumed as part of the diet. Supplementation with calcium may be associated with an increased risk of MI in people with dietary calcium intake above 805 mg daily, but not in those with dietary calcium intake below 805 mg daily (17482). To minimize the possible risk of CVD, CHD, or MI, advise patients not to consume more than the recommended daily intake of 1000-1200 mg and to consider total calcium intake from both dietary and supplemental sources (17484). While dietary intake of calcium is preferred over supplemental intake, advise patients who require calcium supplements to take calcium along with vitamin D, as this combination does not appear to be associated with an increased risk of MI (93533).
Rarely, calcium intake can increase the risk of calciphylaxis, which usually occurs in patients with kidney failure. Calciphylaxis is the deposition of calcium phosphate in arterioles, which causes skin ulcers and skin necrosis. In a case report, a 64-year-old female with a history of neck fracture, sepsis, and ischemic colitis presented with painful leg ulcers due to calciphylaxis. She discontinued calcium and vitamin D supplementation and was treated with sodium thiosulfate and supportive care (95816).

Gastrointestinal ...Orally, calcium can cause belching, flatulence, nausea, gastrointestinal discomfort, and diarrhea (1824,1843,12950,38803). Although constipation is frequently cited as an adverse effect of calcium, there is no scientific substantiation of this side effect (1824,1843,1844,1845,12950,38978). Calcium carbonate has been reported to cause acid rebound, but this is controversial (12935,12936).

Oncologic ...There is some concern that very high doses of calcium might increase the risk of prostate cancer. Some epidemiological evidence suggests that consuming over 2000 mg/day of dietary calcium might increase the risk for prostate cancer (4825,12949). Additional research suggests that calcium intake over 1500 mg/day might increase the risk of advanced prostate cancer and prostate cancer mortality (14132). Consumption of dairy products has also been weakly linked to a small increase in prostate cancer risk (98894). However, contradictory research suggests no association between dietary intake of calcium and overall prostate cancer risk (14131,14132,104630). More evidence is needed to determine the effect of calcium, if any, on prostate cancer risk.

Renal ...Kidney stones have been reported in individuals taking calcium carbonate 1500 mg daily in combination with vitamin D 2000 IU daily for 4 years (93943).

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INULIN

General ...Orally, inulin is well tolerated.
Most Common Adverse Effects:
Orally: Bloating, constipation, diarrhea, flatulence, and gastrointestinal cramps.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis has occurred following consumption of foods high in inulin.

Gastrointestinal ...Orally, inulin may cause flatulence, bloating, diarrhea, constipation, and gastrointestinal cramps, especially at doses over 30 grams (7604,8450,8509,93716,93721,93724,96836,96850,96851,99843)(107936,107940,107941,110602).

Immunologic ...Severe allergic reactions to inulin-containing foods have been reported. There is one report of anaphylaxis following consumption of foods with a high concentration of inulin including salsify, artichoke leaves, and margarine (7608).

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LECITHIN

General ...Orally, lecithin is well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, fullness, and nausea.

Dermatologic ...Orally, lecithin can cause allergic skin reactions in people with egg or soy allergies (15705).

Gastrointestinal ...Orally, lecithin may cause abdominal pain, diarrhea, fullness, and nausea (5140,6243,14817,14822,14838,19204,59281).

Neurologic/CNS ...Orally, lecithin caused CNS complaints and agitation in one patient in a clinical trial (59261).

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SODIUM

General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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WHEY PROTEIN (nondenatured Whey Protein concentrate, nondenatured Whey Protein isolate)

General ...Orally, whey protein is generally well tolerated.
Most Common Adverse Effects:
Orally: Acne, bloating, cramps, diarrhea, fatigue, headache, nausea, reflux, reduced appetite, and thirst. Most adverse effects are dose-related.

Cardiovascular ...In one case report, use of an unclear quantity of whey protein over one month was thought to be probably responsible for the development of coronary embolism in three coronary arteries in a 33-year-old male with no history of atherosclerosis risk factors. The patient required treatment with intravenous glycoprotein IIb/IIIa inhibitor and heparin (96023).

Dermatologic ...Orally, whey protein has been reported to trigger the onset or worsening of acne. Multiple case reports in teenagers and young adults have associated intake of whey protein with the development of acne or the worsening of existing acneiform lesions. In these reports, the discontinuation of whey protein was typically associated with the clearance of acne lesions. In some cases, patients who were unresponsive to acne treatments while using whey protein became responsive after whey protein discontinuation (103965,103970,103971). Cow's milk, which is comprised of 20% whey protein, is also thought to exacerbate acne. It is theorized that this effect may be due to the growth factor and alpha-lactalbumin content of whey protein (103971,103982).

Gastrointestinal ...Orally, whey protein, especially in higher doses of 2. 3-6.5 grams/kg daily, may cause increased bowel movements, nausea, thirst, bloating, esophageal reflux, cramps, and reduced appetite (2640,85961,85702,86043,86074,86075,86084,86089,86095).

Hepatic ...In two case reports, acute cholestatic liver injury occurred after consumption of the combination of whey protein and creatine supplements (46701,90319).

Musculoskeletal ...In one case report, a 26-year-old male experienced fasciitis, or swelling of the forearms, hands, and legs, after consuming the supplement Pure Whey (85895).

Neurologic/CNS ...Orally, high doses of whey protein may cause tiredness or fatigue and headache (2640). Mild drowsiness has also been reported (86089,86092,86124).

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