Clear Protein Mango Mist by NutraBio Performance

EFFECTIVE

• Bowel preparation. Oral sodium phosphate is effective for cleansing the colon in preparation for colonoscopy; however, it is unclear whether sodium phosphate is as effective as polyethylene glycol (PEG) solution. Some products are approved by the US Food and Drug Administration (FDA) for this use. However, due to the potential for kidney damage, sodium phosphate is not recommended as first-line therapy. Details: Sodium phosphate tablets (OsmoPrep, Salix Pharmaceuticals; Visicol, Salix Pharmaceuticals) are FDA-approved for cleansing the colon in preparation for colonoscopy. Clinical research shows that using the OsmoPrep formulation can achieve an "excellent" or "good" response rate, which is defined as having 90% of the mucosa visible with only some or little suctioning needed, in 94% to 97% of patients (88133). Similarly, using the specific product Visicol has been shown to achieve an excellent or good response rate in 82% to 86% of patients (94674). Non-FDA-approved sodium phosphate products have also been investigated. One such product (Fleet Phospho-soda, C. B. Fleet Co.) has been shown to achieve adequate bowel cleansing in 23% to 89% of patients (93846,94673). Another sodium phosphate tablet preparation (Clicolon tablets, Korea Pharma Co.) has been shown to achieve adequate bowel cleansing in 63% to 93% of patients (93848,93850,93853). Excellent or good bowel cleansing was found in 98.6% of patients using a 32-tablet regimen of other sodium phosphate tablets (Quiklean, Universal Integrated Corporation) (107008). Reasons for the differences in the percentage of patients who achieve adequate bowel cleansing with the same sodium phosphate product may relate to the method used to analyze bowel cleansing, differences in diet followed during bowel cleansing, and demographic factors (93846,93848,93850,93853). Various preparations (OsmoPrep, Salix Pharmaceuticals; Visicol, Salix Pharmaceuticals; Clicolon tablets, Korea Pharma Co.; Quiklean, Universal Integrated Corporation) have been used which contain 1.102 grams of sodium phosphate monobasic monohydrate and 0.398 grams of sodium phosphate dibasic anhydrous. These products have been taken as 3-4 tablets with 8 ounces of water every 15 minutes for a total of 20 tablets the evening before colonoscopy, and 3-4 tablets with 8 ounces of water every 15 minutes for a total of 12-20 tablets the morning of a colonoscopy (88133,93848,93850,94674,107008). Also, sodium phosphate solution (Fleet Phospho-soda, C. B. Fleet Co.) containing sodium hydrogen phosphate 24.4 grams and disodium phosphate dodecahydrate 10.8 grams has also been used the morning and evening before the procedure (93846). Numerous publications have compared the bowel cleansing activity of sodium phosphate with PEG solution. When given as a split-overnight dosage, sodium phosphate is about as effective as PEG solutions in achieving adequate bowel cleansing. However, when day-before dosage is used, PEG is more effective for bowel cleansing than sodium phosphate (93861,93862,107008). Sodium phosphate and PEG may have different effectiveness depending on the colonic site assessed. When only trials assessing descending colon cleansing are considered, sodium phosphate is found to work similarly to PEG solutions. When only studies assessing ascending colon cleansing are considered, PEG is more effective for bowel cleansing than sodium phosphate (93861). Also, a large clinical trial in outpatients scheduled for non-sedated colonoscopy shows that receiving PEG resulted in an easier insertion and a less painful colonoscopy when compared with receiving sodium phosphate (104473). However, in patients with chronic constipation, sodium phosphate seems to be preferable. A meta-analysis of three small clinical studies in adults with chronic constipation shows that using sodium phosphate has an 87% greater chance of a successful bowel preparation when compared with using PEG (104472). Sodium phosphate is not recommended as first-line therapy for bowel preparation prior to colonoscopy due to the potential for kidney damage (93863,94672). In fact, one sodium phosphate preparation (Fleet Phospho-soda, C. B. Fleet Co.) that was previously approved as an over-the-counter supplement for bowel preparation in the US was withdrawn from the market for this indication in December 2008 due to concerns for phosphate-induced kidney disease (94672). Of the sodium phosphate products that are still approved by the FDA, current guidelines recommend that these products not be used for bowel cleansing in patients with kidney disease, pre-existing electrolyte disturbances, congestive heart failure, cirrhosis, ascites, or inflammatory bowel disease. Guidelines also recommend that caution should be used if these products are prescribed for patients who are elderly, hypertensive, or taking certain classes of drugs (94672). For small bowel preparation for endoscopy, a meta-analysis suggests that sodium phosphate is no more effective than fasting alone (93860).
• Hypophosphatemia. Oral or intravenous phosphate salts are effective for the prevention or treatment of hypophosphatemia. Some products are approved by the US Food and Drug Administration (FDA) for this use. Details: Taking sodium or potassium phosphate orally is effective for preventing and treating hypophosphatemia (15). Treating hypophosphatemia with oral phosphates requires monitoring of serum electrolyte levels to determine appropriate dosing (15). The FDA-approved intravenous (IV) product is also used for the correction of hypophosphatemia (8302,8303,88135). FDA-approved intravenous (IV) sodium phosphate or potassium phosphate 15-30 mmol is typically given over 2-12 hours. Higher doses have been used if needed to increase efficacy (8302,8303,88135).

LIKELY EFFECTIVE

• Constipation. Oral or rectal sodium phosphate is approved by the US Food and Drug Administration (FDA) as an ingredient in over-the-counter (OTC) products to treat constipation. Details: Sodium phosphate is an FDA-permitted ingredient of oral and rectal OTC products intended for the treatment of constipation (88107).
• Dyspepsia. Oral aluminum phosphate and calcium phosphate are approved by the US Food and Drug Administration (FDA) as ingredients in over-the-counter (OTC) antacids. Details: Aluminum phosphate and calcium phosphate are FDA-permitted ingredients of oral OTC products intended for use as antacids (88107).
• Hypercalcemia. Although other treatments are preferred, oral non-calcium phosphate salts are beneficial for treatment of mild to moderate hypercalcemia. Details: Taking phosphate salts (except calcium phosphate) orally is effective for treating mild to moderate hypercalcemia (88144,88145). Treating hypercalcemia with oral phosphates requires monitoring of serum electrolyte levels to determine appropriate dosing (15); other agents are now preferred (6479). Intravenous phosphates should be avoided due to the risk of calcium precipitation in vital organs (metastatic calcification) (15,88144,88145).

POSSIBLY EFFECTIVE

• Kidney stones (nephrolithiasis). Oral potassium phosphate seems to be beneficial for prevention of kidney stones in individuals with hypercalciuria. Details: Taking potassium phosphate orally may help prevent calcium oxalate kidney stones in patients with hypercalciuria (6470). Clinical research in adults with absorptive hypercalciuria and at high risk for stone formation shows that taking a specific slow-release potassium phosphate product (Uro-Phos-K, Mission Pharmacal), providing phosphate 620 mg orally twice daily for 4 days, reduces urinary calcium excretion by 35% to 40% (2208,2209). Potassium and sodium phosphate salts providing 1200-1500 mg of elemental phosphate daily have been used (2209,6470).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. The evidence is mixed as to whether oral sodium phosphate improves cycling or running performance. Most research suggests that oral calcium phosphate and potassium phosphate are not beneficial. Details: Clinical research shows that taking calcium phosphate or potassium phosphate orally does not improve running or cycling performance (2499,9300,8301). Evidence for the use of sodium phosphate to improve cycling performance is mixed. One very small clinical study shows that taking sodium phosphate as tribasic sodium phosphate dodecahydrate for 6 days before a 10-mile cycling trial increases mean power output by about 10% and decreases the time needed to complete the trial by 3% in trained male cyclists (88150). Other small clinical trials in trained cyclists show that taking the same form of sodium phosphate as 50 mg/kg of fat-free mass in four divided doses daily for 6 days modestly improves work, power output, and peak oxygen uptake and reduces heart rate during high-intensity cycling exercise when compared to baseline (93857,93858,93859,107007). However, conflicting research shows that taking a similar dosage of this form of sodium phosphate does not improve time trial performance, work accomplished relative to energy expenditure, power output, or oxygen uptake in trained cyclists (93855,93856,107007). Sodium phosphate has also been evaluated for improving running performance, with mixed findings. Two small clinical trials in female athletes show that tribasic sodium phosphate dodecahydrate 50 mg/kg of fat-free mass taken in four divided doses daily for 6 days moderately improves repeated sprint times when compared with placebo (93843,93844). However, taking the same dosage does not significantly improve sprint times in male athletes (93849). Also, sodium phosphate does not seem to improve endurance or aerobic capacity in treadmill tests (8301,93854). Reasons for the discrepancies regarding the effects of sodium phosphate on athletic performance are not entirely clear, but likely relate to the very small number of participants in the included trials.
• Diabetic ketoacidosis. Potassium phosphate infusion is not recommended as first-line therapy for adults with diabetic ketoacidosis. Details: Clinical research shows that intravenous infusion of potassium phosphate 8.5 mmol/hour (approximately 6 grams of phosphate over 24 hours) along with potassium chloride 12.5 mEq/hour provides no benefit over potassium chloride alone in adults with diabetic ketoacidosis (88149). Guidelines for the treatment of diabetic ketoacidosis in the both the US and UK do not recommend phosphate replacement for most patients. However, it may be considered in specific cases, such as cardiac dysfunction, anemia, respiratory depression, and serum phosphate concentrations below 1 mg/dL (107349,107350A).
• Osteoporosis. Calcium phosphate seems to be beneficial for bone density improvement; however, it does not seem to be more beneficial than calcium carbonate. Details: In postmenopausal adults with osteoporosis and low phosphate intakes, taking calcium 1800 mg daily as tricalcium phosphate for 12 months improves lumbar spine and hip densities. However, it is no more effective than taking the same amount of calcium as calcium carbonate (93847). The calcium products were used in combination subcutaneous teriparatide and oral vitamin D (cholecalciferol) 1000 IU daily.
• Refeeding syndrome. It is unclear if intravenous potassium phosphate or sodium phosphate is beneficial for prevention of refeeding syndrome. Details: Preliminary clinical research shows that giving intravenous sodium and potassium phosphates, 50 mmol (1.56 grams) phosphate over 24 hours, prevents the refeeding syndrome seen when restarting adequate nutrition after severe malnutrition or starvation when compared with historical controls (88148). More evidence is needed to rate phosphate salts for these uses.

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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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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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LIKELY SAFE ...when used orally and appropriately short-term (15). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term (104471). Long-term use or high doses used orally or rectally require monitoring of serum electrolytes (2494,2495,2496,2497,2498,3092,112922). ...when used intravenously. Potassium phosphate is an FDA-approved prescription drug (15).

POSSIBLY UNSAFE ...when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 4 grams daily for adults under 70 years and 3 grams daily for adults older than 70. Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when used rectally more frequently than once every 24 hours, in excessive doses, with longer retention enema time, or in older patients with comorbidity or renal impairment (112922). The US Food and Drug Administration (FDA) warns that this may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).

CHILDREN: LIKELY SAFE
when used orally and appropriately at recommended dietary allowances (RDAs). The daily RDAs are: children 1-3 years, 460 mg; children 4-8 years, 500 mg; males and females 9-18 years, 1250 mg (7555). ...when sodium phosphate is used rectally and appropriately, no more than once every 24 hours, short-term in children 2 years and older (104471). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).

CHILDREN: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL) of 3 grams daily for children 1-8 years of age and 4 grams daily for children 9 years and older. Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur (7555). ...when sodium phosphate is used rectally more frequently than once every 24 hours, or in children under 2 years of age or with Hirchsprung disease (112922). The US Food and Drug Administration (FDA) warns that these uses may increase the risk of hyperphosphatemia, dehydration, and electrolyte imbalances leading to kidney and heart damage (104471).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately at the recommended dietary allowance (RDA) of 1250 mg daily for individuals 14-18 years of age and 700 mg daily for those over 18 years of age (7555). ...when sodium phosphate is used rectally and appropriately short-term (15). ...when used intravenously. Intravenous potassium phosphate is an FDA-approved prescription drug (15).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when phosphate (expressed as phosphorus) intake exceeds the tolerable upper intake level (UL). Hyperphosphatemia, resulting in electrolyte disturbances, alterations in calcium homeostasis, and calcification of nonskeletal tissues, may occur. The UL during pregnancy is 3.5 grams daily. During lactation, the UL is 4 grams daily (7555).

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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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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.

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BISPHOSPHONATES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking phosphate salts with bisphosphonates might increase the risk of hypocalcemia.  Details Combining bisphosphonates and phosphate can cause hypocalcemia. In one report, hypocalcemic tetany developed in a patient taking alendronate (Fosamax) who received a large dose of phosphate salts as a pre-operative laxative (14589).

ERDAFITINIB (Balversa) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = A Taking erdafitinib with phosphate salts increases the risk of hyperphosphatemia.  Details Erdafitinib increases phosphate levels. It is recommended that patients taking erdafitinib restrict phosphate intake to no more than 600-800 mg daily (104470).

FUTIBATINIB (Lytgobi) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Likely •  Level of Evidence = A Taking futibatinib with phosphate salts increases the risk of hyperphosphatemia.  Details Futibatinib can cause hyperphosphatemia, as reported in 88% of patients in clinical studies. In addition, 77% of patients in clinical studies required use of a phosphate binder to manage hyperphosphatemia. Phosphate salts should generally be avoided by people taking this medication (112912).

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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.

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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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General ...Orally, intravenously, and rectally, phosphate salts are generally well tolerated when used appropriately and/or as prescribed.
Most Common Adverse Effects:
Orally: Abdominal pain, anal irritation, bloating, diarrhea, headache, gastrointestinal irritation, hyperphosphatemia, hypocalcemia, malaise, nausea, sleep disturbance, and vomiting.
Rectally: Hyperphosphatemia and hypocalcemia.
Serious Adverse Effects (Rare):
Orally: Extraskeletal calcification.

Cardiovascular ...Orally, a case of allergic acute coronary syndrome e., Kounis syndrome) is reported in a 43-year-old female after ingesting a specific sodium phosphate laxative product (Travad oral). She presented with maculopapular rash that progressed to anaphylaxis and a non-ST elevation acute coronary syndrome. The patient recovered after hospitalization for 3 days with medical management (112894).

Gastrointestinal ...Orally, phosphate salts can cause gastrointestinal irritation, nausea, abdominal pain, bloating, anal irritation, and vomiting (15,2494,2495,2496,2497,93846,93848,93850,93851,93853,107008). Sodium and potassium phosphates can cause diarrhea (15). Aluminum phosphate can cause constipation (15). A large comparative study shows that, when taken orally as a bowel preparation for colonoscopy, sodium phosphate is associated with gastric mucosal lesions in about 4% of patients (93868).

Neurologic/CNS ...Orally, phosphate salts can commonly cause malaise (93846). Headaches and sleep disturbance may also occur (93848,93851).

Renal ...Orally, use of sodium phosphate for bowel cleansing has been associated with an increased risk of acute kidney injury in some patients (93863). However, a pooled analysis of clinical research suggests that results are not consistent for all patients (93864). Some evidence suggests that female gender, probably due to lower body weight, iron-deficiency anemia, dehydration, and chronic kidney disease are all associated with an increased risk of sodium phosphate-induced kidney dysfunction (93865).

Other ...Orally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia, and extraskeletal calcification. Potassium phosphates can cause hyperkalemia. Sodium phosphates can cause hypernatremia and hypokalemia (15,2494,2495,2496,2497,107008).
Rectally, phosphate salts can cause fluid and electrolyte disturbances including hyperphosphatemia and hypocalcemia (15,112922).
Deaths related to intake of oral or rectal phosphate salts are rare and most have occurred in infants and are related to overdose (93866). However, death has also been reported in elderly patients using sodium phosphate enemas, mainly at standard doses of 250 mL (93867).

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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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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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