MD Protein Sustainable Plant-Based Creamy Vanilla Flavor by Garden of Life Dr. Formulated

LIKELY EFFECTIVE

• Coronary heart disease (CHD). Consuming products containing at least 3.6 grams of soluble fiber, including beta-glucans, per day may reduce the risk of CHD when consumed as part of a diet low in saturated fat and cholesterol. Details: Clinical research shows that a diet containing foods high in beta-glucans, such as oats and barley, reduces the risk of heart disease (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the FDA approved a health claim stating that consuming products containing at least 3 grams of beta-glucans per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Dyslipidemia. Oral beta-glucans modestly reduces low-density lipoprotein (LDL) cholesterol levels. Details: Although some research disagrees, most clinical research shows that taking barley- or oat-derived beta-glucans 3-10 grams daily for up to 12 weeks or yeast-derived beta-glucans 7.5 grams twice daily for 7-8 weeks can reduce LDL and total cholesterol levels when used for up to 12 weeks (5790,5796,7272,17129,34700,34727,34729,34765,34766,34811)(34812,34876). Meta-analyses of available clinical research on oat-derived beta-glucans show that taking at least 3 grams daily reduces LDL cholesterol by around 4-10 mg/dL and total cholesterol by 4-12 mg/dL but does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels when compared with control diets (92660,97987,112225). Consuming oat-derived beta-glucans also reduces apolipoprotein B (apoB) levels by 0.54 mg/dL when compared with control diets (97987). The effects of oat-derived beta-glucans on cholesterol levels appear to be greater in patients with diabetes and those with higher LDL cholesterol levels (92660,97987). A meta-analysis of available clinical research on barley-derived beta-glucans shows that consuming an average of 6.5-7 grams of beta-glucans daily as part of the diet reduces LDL cholesterol levels by 4.5 mg/dL, total cholesterol levels by 5.6 mg/dL, and apoB levels by 0.54 mg/dL when compared with control diets (98204). The form of beta-glucans used may alter the effect of beta-glucans on cholesterol levels. Some research shows that barley that is highly enriched (75% by weight) with beta-glucans does not significantly affect cholesterol levels. This lack of effect seems to be the result of processing the barley into a highly enriched beta-glucans product (10166). Other clinical research also shows that the processing of beta-glucans products or the food matrix used to make these products might reduce beta-glucans molecular weight and/or solubility and therefore decrease its ability to lower cholesterol levels (10145,34800,34819).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. Although there is interest in using oral or topical beta-glucans for aging, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
• Allergic rhinitis (hay fever). It is unclear if oral beta-glucans are beneficial for reducing symptoms of allergic rhinitis. Details: A small clinical trial in patients allergic to ragweed shows that taking specific yeast-derived beta-glucans (Wellmune WGP) 250 mg daily for 4 weeks decreases the number of allergy symptoms by 28% and the severity of allergy symptoms by 52% when compared with placebo (34859).
• Atopic dermatitis (eczema). It is unclear if topical beta-glucans are beneficial for atopic dermatitis. Details: Preliminary clinical research in children and adults with atopic dermatitis shows that applying a specific cream (Imunoglukan P4H, PLEURAN s.r.o.) containing beta-glucans 0.25% 2-3 times daily for 6 months modestly reduces pruritus, intensity of flares, and overall disease severity when compared with the application of a standard emollient (98201).
• Benign prostatic hyperplasia (BPH). Although there is interest in using oral beta-glucans for BPH, there is insufficient reliable information about the clinical effects of beta-glucans for this purpose.
• Cancer. Although there is interest in using oral beta-glucans for cancer, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Canker sores. It is unclear if oral beta-glucans are beneficial for canker sores. Details: Preliminary clinical research shows that taking beta-glucans 10 mg twice daily for 20 days reduces ulcer severity in patients with recurrent aphthous stomatitis when compared with placebo (34763).
• Chronic fatigue syndrome (CFS). Although there is interest in using oral beta-glucans for CFS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Critical illness (trauma). It is unclear if oral beta-glucans are beneficial for patients with critical illness. Details: Preliminary clinical research shows that taking oat-derived beta-glucans 3 grams daily as part of enteral feeds does not reduce the length of hospital stay, mortality rate, or infection rate when compared with placebo in patients with trauma. However, the length of time on mechanical ventilation was approximately 47% shorter when compared with placebo (100186).
• Diabetes. Small clinical studies in children and adults with type 1 diabetes suggest that beta-glucans do not improve blood glucose levels. It is unclear if oral beta-glucans are beneficial for patients with type 2 diabetes. Details: Some preliminary clinical research in adults with type 2 diabetes shows that consuming oat-derived beta-glucans 3 grams daily in bread for 3 weeks improves insulin resistance and cholesterol levels when compared with control bread (34765). Other preliminary clinical research in patients with type 2 diabetes shows that consuming bread containing oat-derived beta-glucans in a ratio of 7.6 grams per 100 grams of starch daily for 6 months reduces postprandial glucose levels and glycated hemoglobin (HbA1c) when compared with control bread (97986). Additionally, some clinical research shows that replacing a half serving of white rice with beta-glucans-containing barley attenuates increases in postprandial glucose and insulin levels when compared with a full serving of white rice in patients with type 2 diabetes (103887). However, oat-derived beta-glucans 3-3.5 grams daily in bread or soup for 3-8 weeks does not seem to significantly affect fasting plasma glucose levels or HbA1c when compared with control bread or soup (34765,34788). Also, some evidence shows that consuming soup enriched with beta-glucans does not improve cholesterol levels in patients with type 2 diabetes when compared with control soup (34788). The inconsistency in clinical outcomes may be due to differences in the length of treatment, quantity or ratio of beta-glucans consumed, and/or the preparation of the beta-glucans product. In children with type 1 diabetes, consuming a bedtime snack enriched in beta-glucans appears to prevent hypoglycemia prior to midnight, but does not prevent hypoglycemia at later time points when compared with a control snack (34685). In adolescents with type 1 diabetes, a very small clinical study shows that taking a specific oat product (Betaglucare), providing 6 grams beta-glucans, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with 3 grams beta-glucans daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the durations of hypoglycemia or hyperglycemia between groups (105261). However, a small crossover study in adults with type 1 diabetes shows that taking a specific product (Stomacol, Brainbridge Commerce AB) containing beta-glucans 1.53 grams 3 times daily prior to meals for 2 weeks does not alter blood glucose levels when compared with placebo (97983).
• Exercise-induced respiratory infections. There is conflicting evidence about the effects of beta-glucans on respiratory infections in athletes following competitive events. Details: Taking a specific product containing oat beta-glucans (OatVantage) 5.6 grams daily for 14 days does not reduce the number of sick days or the number of upper respiratory tract infections in trained male cyclists when compared with placebo (34746). However, other clinical research shows that taking yeast-derived beta-glucans 250-500 mg daily for 4 weeks beginning on the day after a marathon reduces the occurrence of symptomatic upper respiratory infections by 33% to 50% within 2-4 weeks of treatment when compared with placebo. Health scores, fatigue, and mood also improved (34860,92659). Additional clinical research in marathon runners shows that drinking a beverage containing yeast-derived beta-glucans 250 mg daily for 45 days prior to, the day of, and 45 days after a marathon does not reduce the duration or number of upper respiratory infections, but does seem to reduce the number of symptomatic days and overall severity of upper respiratory symptoms, when compared with placebo (103886). Finally, clinical research in top athletes also shows that taking a specific product containing mushroom-derived beta-glucans (Imunoglukan P4H, PLEURAN s.r.o.) 200 mg with vitamin C 200 mg daily for 3 months reduces the number of subjects with at least four symptoms of upper respiratory tract infection by approximately 85% when compared with vitamin C alone (34809).
• Fibromyalgia. Although there is interest in using oral beta-glucans for fibromyalgia, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Hepatitis. Although there is interest in using oral beta-glucans for hepatitis, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Hypertension. It is unclear if oral beta-glucans are beneficial for hypertension; the available evidence is conflicting. Details: Preliminary clinical research shows that consuming an oat cereal containing beta-glucans 5.52 grams daily for 6 weeks reduces diastolic and systolic blood pressure when compared with a low-fiber cereal in hypertensive adults (34691). However, other clinical research shows that consuming oat-based cereals enriched in beta-glucans for 12 weeks does not reduce blood pressure in individuals with hypertension. A reduction in blood pressure occurred in a sub-group of these individuals with a body mass index greater than 31.5 kg/m2 (34684,34722).
• Inflammatory bowel disease (IBD). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in adults with IBD and symptoms of irritable bowel syndrome shows that taking a combination of beta-glucans, inositol, and digestive enzymes daily for 4 weeks, in conjunction with mesalamine, reduces evacuative urgency when compared with mesalamine alone. Taking this combination product also reduces abdominal pain, bloating, and gas when compared with baseline, but not when compared with taking mesalamine alone (97984).
• Irritable bowel syndrome (IBS). Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking one pill twice daily of a specific combination product (Biointol, BioActivaL) containing beta-glucans, inositol, and digestive enzymes for 4 weeks reduces pain, bloating, and gas, but not other symptoms of IBS, when compared with no treatment (34818). It is not clear if these effects are due to beta-glucans, the other ingredients, or the combination.
• Laser skin resurfacing. It is unclear if topical beta-glucans are beneficial for improving recovery from laser skin resurfacing. Details: In patients that had received fractional laser therapy for atrophic acne scars, preliminary clinical research shows that topical application of skin care products containing beta-glucans, including dressings, solutions, and creams, (Dermdoc, Songyang Biotechnology Co. Ltd) once daily to one side of the face for 14 days modestly increases hydration and reduces redness when compared with the other side of the face treated with the vehicle alone (105263).
• Lower respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of lower respiratory tract infections when compared with no treatment. In the four months after treatment completion, the number of infections was reduced by about 50%; however, the total number of infections in each group was small. The dose was 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Lyme disease. Although there is interest in using oral beta-glucans for Lyme disease, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Metabolic syndrome. It is unclear if oral beta-glucans are beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome or at high risk for metabolic syndrome shows that eating 200 grams of bread enriched with 6% barley-derived beta-glucans daily for 4 weeks as part of the diet does not alter most metabolic parameters when compared with baseline. However, there was a small reduction in total cholesterol (100185). The validity of this finding is limited by the lack of a comparator group.
• Multiple sclerosis (MS). Although there is interest in using oral beta-glucans for MS, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Neuroblastoma. It is unclear if oral beta-glucans is beneficial in children or young adults with neuroblastoma. Details: Clinical research in children and young adults with relapsed or refractory high-risk neuroblastoma shows that taking yeast-derived beta-glucans for 17 days, starting four days before treatment with intravenous anti-GD2 murine monoclonal antibody for a total of 10 days, results in progression-free and overall survival rates of 28% and 61%, respectively, after 2 years, and 19% and 36%, respectively, after 5 years. Doses of beta-glucans ranged from 10-200 mg/kg daily and each patient completed 1-4 treatment cycles (109203). The validity of these findings is limited by the lack of statistical comparison to a control group. A large clinical study in children and young adults with high-risk neuroblastoma receiving subcutaneous GD2/GD3 vaccine shows that taking beta-glucans 40 mg/kg/day for 14 days as a primer to the vaccine improves the IgG antibody response at 32 weeks when compared with controls who started taking beta-glucans 6 weeks after vaccination. However, taking beta-glucans prior to vaccination does not improve overall or progression-free survival at approximately 20 months (112227). This study may have been inadequately powered to detect a difference in survival between groups.
• Obesity. It is unclear if oral beta-glucans are beneficial for obesity. Details: A meta-analysis of 20 randomized controlled trials shows that taking beta-glucans reduces body weight by about 0.8 kg and body mass index (BMI) by about 0.6 kg/m2 when compared with not taking beta-glucans. However, there was no effect on waist circumference. Also, populations included in this meta-analysis included those with obesity, as well as healthy individuals and patients with diabetes or hypercholesterolemia (100183). Results from individual clinical trials are mixed, with some showing modest reductions in body weight, BMI, and/or waist circumference, and others showing no effect (34790,98202,98203,100183,109208). This research has evaluated barley-, oat-, or yeast-derived beta-glucans at doses between 0.88-9 grams daily for 0.4-12 weeks (34790,98202,98203,100183,109208). Also, a capsule containing yeast-derived beta-glucans 477 mg has been taken daily for 2 weeks, then twice daily for 4 weeks (98203). Beta-glucans have also been taken in combination with other ingredients. For example, barley-derived beta-glucans 2.2 grams has been mixed with rice and consumed twice daily with meals for 12 weeks (98202) and oat-derived beta-glucans (B-Can, Garuda International, Inc.) 2.5 grams has been taken with green coffee polyphenols 300 mg twice daily for 8 weeks (109208). The inconsistency in clinical outcomes may be due to the heterogenous patient populations, as well as the differing sources, doses, and dosage forms of beta-glucans used.
• Otitis media. Although there is interest in using oral beta-glucans for otitis media, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Postoperative pain. It is unclear if oral beta-glucans are beneficial for reducing abdominal pain after surgery for intestinal polyps. Details: Preliminary clinical research in patients who underwent surgical removal of intestinal polyps shows that eating bread containing barley beta-glucans 3 grams daily for 3 months reduces bloating and abdominal pain when compared with eating bread that does not contain beta-glucans (34813).
• Respiratory tract infections. Oral beta-glucans have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 reduces the duration of respiratory tract infections by about 1.7 days and modestly improves parent-perceived symptom severity and effectiveness when compared with no treatment. However, there was no effect on the number of total, upper, or lower respiratory tract infections, the use of antibiotics or antipyretics, or the number of days missed from school. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Rheumatoid arthritis (RA). Although there is interest in using oral beta-glucans for RA, there is insufficient reliable information about the clinical effects of beta-glucans for this condition.
• Stretch marks (striae gravidarum). It is unclear if topical beta-glucans are beneficial for stretch marks. Details: Preliminary clinical research shows that a specific topical serum and emulsion (Awake; Hangzhou Songyang Biotechnical) containing beta-glucans, applied twice daily for 12 weeks, modestly improves patient-scored, but not physician-scored, stretch mark appearance when compared with a vehicle control. When beta-glucans are used in combination with 1565-nm non-ablative fractional laser once every 4 weeks for 12 weeks, scar atrophy is modestly improved when compared with either treatment alone (109210). However, it is unclear if any changes would be considered clinically significant.
• Upper respiratory tract infection (URTI). It is unclear if oral beta-glucans are beneficial for the prevention of URTIs in adults or children. Details: A meta-analysis of clinical research shows that taking yeast-derived beta-glucans reduces the odds of developing a URTI in generally healthy individuals by approximately 65% when compared with placebo. There was also a small to medium effect on the overall incidence and duration of URTIs. Doses ranged from 35-900 mg daily for 4-26 weeks (105264). However, the results from this analysis were heterogeneous and the number of studies included was small. One study included in the analysis used a specific product containing yeast-derived beta-glucans (Wellmune WGP) 500 mg daily for 12 weeks and found no effect on the number or duration of overall symptomatic infections or the number or duration of specific types of respiratory infections when compared with placebo. However, there was an improvement in quality of life and a reduction in the number of missed work days (34879). Beta-glucans have also been evaluated for the prevention of URTI in children. A small clinical study in children aged 2-6 years with recurrent respiratory tract infections shows that taking a specific combination product (Stimunex gocce) containing beta-glucans, elderberry extract, zinc, and vitamin D3 does not reduce the number or duration of upper respiratory tract infections when compared with no treatment. At four months after treatment completion, the number of infections was reduced by about 44%; however, the total number of infections in both groups was small. The product was dosed as 1 drop/kg daily for one month, followed by 1 drop/kg daily for 15 consecutive days each month for the next three months (109212).
• Wound healing. Although there is interest in using topical beta-glucans for healing of wounds, burns, skin ulcers, and dermatitis, there is insufficient reliable information about the clinical effects of beta-glucans for these purposes. More evidence is needed to rate beta-glucans for these uses.

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POSSIBLY EFFECTIVE

• Constipation. Oral guar gum may improve symptoms and stool frequency in adults and children with constipation. Details: Several small clinical studies in adults show that taking partially hydrolyzed guar gum increases stool frequency and relieves straining and pain when compared to baseline. Studied doses include 4-12 grams daily for up to 8 weeks or 11 grams twice daily for up to 3 weeks (12548,25073,93619). Small clinical studies in children with constipation also show that taking guar gum 3-5 grams daily for 4 weeks or partially hydrolyzed guar gum 6 grams daily for 2-15 months moderately increases bowel movement frequency and decreases abdominal pain when compared to baseline (93605,101889). While these improvements appear to be similar to those reported in children treated with lactulose (93605), a direct comparison is lacking.
• Diarrhea. Oral guar gum may reduce the duration of diarrhea in adults and children. Details: Two small clinical studies in patients in the intensive care unit show that adding guar gum 2% or 22 grams/L to enteral feeding formula reduces the number of liquid stools and decreases the percentage of days with diarrhea by around 70% when compared with control enteral formula (10325,54239). A larger clinical trial in children with acute watery diarrhea due to infections also shows that taking guar gum reduces the duration of diarrhea by around 16 hours when compared with a control (54210). Another clinical study in children with persistent watery diarrhea also shows that adding guar gum 20 grams/L daily for 7 days to a comminuted chicken diet improves the odds of diarrhea resolution after 7 days by 3-fold when compared with the chicken diet alone (54243).
• Hypercholesterolemia. Oral guar gum, taken alone or with other dietary fibers, may reduce cholesterol levels in patients with hypercholesterolemia. Details: Several small clinical trials in patients with hypercholesterolemia show that taking guar gum 15-18 grams in single or divided doses daily for up to 24 months lowers cholesterol levels when compared with baseline levels or placebo (4971,10897,54314,54318,54333). Additionally, a meta-analysis of 25 small clinical studies in patients with hypercholesterolemia, diabetes, hypertension, or metabolic syndrome shows that guar gum reduces total cholesterol by around 20 mg/dL and low-density lipoprotein (LDL) cholesterol by around 17 mg/dL, but does not reduce triglyceride levels, when compared with controls. Subgroup analyses suggest that improvements in total and LDL cholesterol are greater in patients with hypercholesterolemia and in those taking at least 15 grams of guar gum daily (107930). Additional clinical evidence shows that taking guar gum along with other dietary fibers can reduce cholesterol levels. Taking 20 grams of a mixture containing guar gum, pectin, and a small amount of the insoluble fibers from soy, pea, and corn bran daily for 36 weeks lowers total and LDL cholesterol, but does not affect high-density lipoprotein (HDL) cholesterol or triglyceride levels (12547,54335). Also, taking a specific product containing guar gum and psyllium (Minolest) 16.5 grams daily for 3 months reduces total and LDL cholesterol when compared with placebo, but does not affect triglyceride levels (54206). Taking 15 grams of a combination of guar gum, psyllium, pectin, and carob gum daily for 6 months also appears to reduce total and LDL cholesterol when compared to baseline (8431).
• Hypertension. Oral guar gum may modestly reduce systolic and diastolic blood pressure, although these reductions may not be considered clinically significant. Details: Several small clinical trials in patients with hypertension show that taking guar gum 7-10 grams with each meal daily for up to 6 weeks modestly reduces systolic and diastolic blood pressure when compared with placebo (54232,54304,54320). However, guar gum does not appear to be as effective for reducing blood pressure as psyllium husk (54260). A meta-analysis of clinical trials in adults also shows that taking guar gum 1-30 grams daily for 6 weeks to 6 months reduces systolic and diastolic blood pressure by approximately 1 mmHg when compared with placebo or no intervention. However, many patients included in these trials did not have hypertension at baseline. Sub-analyses suggest that the effects of guar gum on blood pressure may be larger in patients with hypertension. The validity of this meta-analysis is limited by high heterogeneity (105507).
• Irritable bowel syndrome (IBS). Oral guar gum may improve bowel function and abdominal pain in adults and children with IBS. Details: Clinical trials in adults with IBS show that taking guar gum 5-10 grams daily for 12 weeks improves abdominal pain, bowel function, and quality of life when compared with baseline or wheat bran (10326,54245). A small clinical study in children 8-16 years of age with chronic abdominal pain and IBS shows that taking partially hydrolyzed guar gum 5 grams daily for 4 weeks decreases symptom frequency and normalizes bowel movements when compared with placebo. However, it does not improve abdominal pain (93615). Another small clinical trial in children 1-18 years of age with IBS shows that taking a specific guar gum product (Resource Optifibre, Nestle HealthCare Nutrition) for at least 6-8 weeks improves stool consistency and abdominal pain when compared to baseline (93621).

POSSIBLY INEFFECTIVE

• Obesity. Oral guar gum may not improve body weight in patients with obesity. Details: Several small clinical trials in overweight or obese adults show that taking guar gum 10.5-20 grams in divided doses daily for up to 14 months does not reduce body weight or improve satiety when compared with placebo or other controls (54212,54260,54353,54360). Additionally, a meta-analysis of 11 small clinical studies of various patient populations, including postmenopausal adults and those with hyperlipidemia or diabetes, shows that taking guar gum 7.5-21 grams daily for 3 weeks to 6 months does not reduce body weight when compared with placebo (8305).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anal fissures. It is unclear if oral guar gum is beneficial in patients with anal fissures. Details: A small clinical study in patients with chronic anal fissures treated with topical application of glyceryl trinitrate shows that taking partially hydrolyzed guar gum 5 grams daily as maintenance therapy for a total of 10 months increases success rate by 53% and decreases the risk for recurrence of anal fissures by 52% when compared with control (93617).
• Autism spectrum disorder. It is unclear if oral guar gum is beneficial in children with autism spectrum disorder. Details: A very small clinical study in children 4-9 years of age with autism and constipation shows that taking partially hydrolyzed guar gum (Sunfiber, Taiyo Kagaku Co. Ltd.) 6 grams daily for 2-15 months moderately improves irritability, but not other measures of behavior, when compared to baseline (101889). The validity of this finding is limited by the lack of a comparator group.
• Chemotherapy-induced diarrhea. It is unclear if oral guar gum is beneficial for the prevention or treatment of chemotherapy-induced diarrhea. Details: A clinical study in patients receiving 5-fluorouracil chemotherapy for colorectal cancer shows that adding guar gum (Novasource GI control, Novartis Nutrition) 11 grams daily on cycle days 7-14 for 24 weeks to treatment with Lacticaseibacillus rhamnosus GG does not reduce the rate of severe diarrhea or other abdominal complaints when compared with no treatment or L. rhamnosus GG alone (16736).
• Cholera. It is unclear if oral guar gum is beneficial for improving diarrhea in patients with cholera. Details: A small clinical study in adults with cholera treated with doxycycline shows that adding guar gum 25-50 grams to oral rehydration solution for 2 days does not reduce the duration of diarrhea, but might reduce stool weight over the first 24 hours, when compared with oral rehydration solution alone (54262).
• Cholestasis. Small clinical studies suggest that oral guar gum may not improve symptoms of cholestasis during pregnancy. Details: Two small clinical studies in patients with cholestasis during pregnancy show that taking a specific granulated guar gum product (Guarem, Orion Pharmaceutical) 5-15 grams daily until delivery does not reduce the intensity of pruritus or improve liver function when compared with placebo (54209,54356).
• Diabetes. Small clinical studies suggest that oral guar gum might improve postprandial glucose levels in patients with type 1 diabetes; whether guar gum is effective for improving glycemic control in patients with type 2 diabetes is unclear. Details: Two small clinical studies in patients with type 1 diabetes show that taking guar gum 5 grams with meals four times daily for 4-6 weeks lowers postprandial glucose levels when compared with placebo (10896,12545). However, clinical trials in patients with type 2 diabetes show conflicting results. Several very small clinical studies suggest that taking guar gum 5-7.6 grams with each meal daily for up to 48 weeks lowers blood glucose when compared with baseline levels or placebo in patients with type 2 diabetes (12540,12541,12542,12543,12544). However, other small clinical trials in these patients show that taking guar gum 5-7 grams with each meal for up to 3 months does not improve glycemic control (54270,54275,54320,54326). The reasons for these discrepant findings are unclear; however, all of the studies in patients with type 2 diabetes were very small and likely underpowered to identify significant treatment effects. In addition to glycemic control, the effect of guar gum on serum lipids in patients with diabetes has also been evaluated. A meta-analysis of 11 small clinical studies in patients with type 2 diabetes with or without hypercholesterolemia shows that taking guar gum 5-30 grams daily for up to 6 months reduces total cholesterol by around 20 mg/dL and low-density lipoprotein (LDL) cholesterol by around 15 mg/dL. Doses of guar gum 20 grams daily or greater also appear to reduce triglyceride levels by around 13 mg/dL, while lower doses have no effect (107929).
• Influenza. It is unclear if oral guar gum is beneficial for the prevention of influenza. Details: Observational research in hospitalized patients has found that taking partially hydrolyzed guar gum 5.2 grams daily for the duration of a hospital stay is associated with a lower risk of influenza when compared with those not taking guar gum. One additional case of influenza appears to be prevented for every 14 patients taking guar gum over placebo (107928).
• Malnourishment-related diarrhea. It is unclear if oral guar gum is beneficial in children with malnourishment-related diarrhea. Details: A small clinical study in children aged 6-36 months with acute watery diarrhea related to malnutrition shows that adding guar gum 15 grams/L to oral rehydration solution reduces the duration of diarrhea by around 18 hours when compared with oral rehydration solution alone (93616).
• Postprandial hypotension. Small clinical studies suggest that oral guar gum may be beneficial for the prevention of postprandial hypotension in older females and patients with type 2 diabetes. Details: A small clinical study in older females with postprandial hypotension shows that taking guar gum 9 grams along with a meal decreases the risk of postprandial hypotension by 75% when compared with placebo (93618). Another small clinical study in patients with type 2 diabetes shows that taking guar gum 9 grams prior to a meal reduces the risk of postprandial decreases in blood pressure when compared to baseline (12540).
• Small intestinal bacterial overgrowth (SIBO). It is unclear if oral guar gum is beneficial in patients with SIBO. Details: A small clinical study in patients with SIBO shows that taking guar gum 5 grams daily along with rifaximin 1200 mg daily for 10 days increases the chance for eradication of SIBO by 37% to 40% when compared with rifaximin alone. However, overall clinical improvement appears to be similar for guar gum plus rifaximin and rifaximin alone (93622). More evidence is needed to rate guar gum for these uses.

(Read more about GUAR GUM)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dental plaque. It is unclear if oral or topical gum arabic is beneficial for preventing or treating dental plaque. Details: Preliminary clinical research shows that chewing gum arabic for 10 minutes, five times daily for 7 days, reduces dental plaque when compared with chewing sugar-free gum (30220). Another small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces dental plaque in patients with moderate, but not high, plaque accumulation when compared with placebo (111508). Gum arabic has also been evaluated in combination with other ingredients for this purpose. A small clinical study shows that applying a pea-size amount of gel containing gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases plaque severity when compared with placebo. The gel is similar in effectiveness to chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Diabetes. It is unclear if oral gum arabic is beneficial in patients with diabetes. Details: Clinical research in adults with type 2 diabetes who are taking oral antidiabetes medications shows that taking gum arabic powder 30 grams daily in the morning for 3 months modestly reduces fasting blood glucose and glycated hemoglobin (HbA1c) when compared with baseline. Gum arabic also modestly reduces low-density lipoprotein (LDL) cholesterol levels, body mass index, and hip circumference, but not waist circumference or blood pressure, when compared with baseline (98700,99098). The validity of these findings is limited by the lack of a comparison to the placebo group.
• Gingivitis. It is unclear if topical gum arabic is beneficial in patients with gingivitis. Details: A small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces gingival inflammation in patients with mild, but not moderate, gingivitis when compared with placebo (111508). Another small clinical study in patients with chronic gingivitis shows that applying a pea-size amount of gel containing a mixture of ingredients including gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases gingivitis severity when compared with placebo. The gel was no better than using chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Hypercholesterolemia. It is unclear if oral gum arabic helps to reduce high cholesterol levels. Details: One small clinical study in patients with hypercholesterolemia shows that taking gum arabic 5 grams twice daily for 4 weeks does not seem to affect plasma lipid levels when compared with baseline (8072).
• Irritable bowel syndrome (IBS). Although there is interest in using oral gum arabic for IBS, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Kidney failure. Although there is interest in using oral gum arabic for kidney failure, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Metabolic syndrome. It is unclear if oral gum arabic is beneficial for preventing metabolic syndrome. Details: One small clinical study in healthy adults at risk for metabolic syndrome shows that taking gum arabic 20 grams daily for 12 weeks modestly reduces blood pressure and increases fat-free mass when compared with baseline, but not when compared with taking pectin 1 gram. There were no changes in weight, glycated hemoglobin, or cholesterol levels (105039).
• Obesity. It is unclear if oral gum arabic is beneficial for promoting weight loss. Details: One small clinical study in healthy adults shows that taking powdered gum arabic 18 grams in the morning and 12 grams in the evening for 6 weeks reduces body mass index by 0.32 kg/m2 and body fat percentage by about 2% when compared with placebo. Body weight was also reduced by 1.2%, but this was not significant when compared with placebo (18237). It is unclear if gum arabic is beneficial in individuals with obesity.
• Peristomal lesions. It is unclear if topical gum arabic is beneficial for preventing peristomal lesions in patients with a colostomy bag. Details: Preliminary clinical research in infants shows that applying a thick layer of gum arabic gel to peristomal skin before attaching a colostomy bag twice daily for 4 weeks decreases the incidence of postoperative peristomal dermatitis by about 78% when compared with zinc sulfate ointment (92886).
• Sickle cell disease. It is unclear if oral gum arabic is beneficial in patients with sickle cell disease. Details: Preliminary clinical research in patients with sickle cell disease shows that taking gum arabic powder 30 grams daily for 12 weeks does not improve most markers of liver and kidney function in these patients. While an improvement in direct bilirubin levels was observed when compared to baseline, no significant changes in serum levels of total bilirubin, albumin, protein, liver enzymes, urea, or creatinine were reported (102087). However, in this same group of patients, gum arabic did reduce levels of total cholesterol by 8 mg/dL, low-density lipoprotein (LDL) cholesterol by 5 mg/dL, and triglycerides by 12 mg/dL when compared with baseline. Significant improvements in high-density lipoprotein (HDL) cholesterol were lacking (102088). This research is limited by the lack of a control group, Also, it is unclear whether gum arabic can improve clinical outcomes in patients with sickle cell disease. More evidence is needed to rate the effectiveness of gum arabic for these uses.

(Read more about GUM ARABIC)

POSSIBLY EFFECTIVE

• Cachexia. Intravenous MCTs can provide calories in critically ill patients and patients with refractory cachexia, but do not seem to offer any advantages over long chain triglycerides. Details: Several small clinical studies in critically ill patients and patients with refractory cachexia secondary to cancer show that receiving parenteral nutrition with a 1:1 mixture of MCTs and long chain triglycerides is similarly effective to long chain triglycerides alone for improving metabolic parameters or nutritional status (2275,2276,93739).

POSSIBLY INEFFECTIVE

• HIV/AIDS-related wasting. Oral MCTs do not seem to promote weight gain or prevent weight loss in patients with HIV infection. Details: A large clinical study in patients with HIV infection shows that taking a peptide-based supplement containing MCTs (Peptamen Oral Complete Elemental Diet, Nestlé Clinical Nutrition) with multivitamins and minerals is no more effective than taking multivitamins and minerals alone for promoting weight gain or preventing weight loss (11730).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral MCTs are beneficial in patients with age-related cognitive decline. Details: A small, single-blind clinical study in older adults residing in a nursing home shows that taking MCTs 6 grams (a 3:1 mixture of caprylic acid:capric acid), with or without L-leucine 1.2 grams and vitamin D (cholecalciferol) 20 mcg, daily for up to 3 months increases mini-mental state exam (MMSE) scores by an average of 3.5 points, compared with a 0.7-point decline in those receiving a long chain triglyceride control. MMSE scores returned to baseline 1.5 months after discontinuation of MCT supplementation (105710).
• Alzheimer disease. Small clinical studies suggest that oral MCTs do not improve cognition in patients with Alzheimer disease or mild cognitive impairment. Details: A meta-analysis of small clinical studies in patients with Alzheimer disease or mild cognitive impairment shows that taking MCTs (as combinations of caprylic acid and capric acid) in doses of 20-56 grams or 22.5-165 mL daily for up to 6 months does not improve cognition when compared with placebo or baseline (103012).
• Athletic performance. It is unclear if oral MCTs are beneficial for endurance athletic performance. Details: A very small clinical study in 10 male recreational endurance runners shows that taking a ketone supplement containing MCTs and a salt form of beta-hydroxybutyrate 60 minutes prior to a run does not improve 5-kilometer run time when compared with placebo (107738). This study may have been inadequately powered to detect a difference between groups.
• Celiac disease. Although there has been interest in using oral MCTs for celiac disease, there is insufficient reliable information about the clinical effects of MCTs for this purpose.
• Chylothorax. It is unclear if oral MCTs improve time to resolution of spontaneous congenital chylothorax in neonates. Details: A small retrospective study in neonates with spontaneous congenital chylothorax shows that administering MCTs does not improve the time to resolution of chylothorax when compared with total parenteral nutrition (11729).
• Chyluria. Although there has been interest in using oral MCTs for chyluria, there is insufficient reliable information about the clinical effects of MCTs for this purpose.
• Cystic fibrosis. Although there has been interest in using oral MCTs for cystic fibrosis, there is insufficient reliable information about the clinical effects of MCTs for this purpose.
• Diabetes. Although there has been interest in using oral MCTs for diabetes, there is insufficient reliable information about the clinical effects of MCTs for this purpose.
• Epilepsy. It is unclear if oral MCTs are beneficial in adults and adolescents aged 12 years or older with drug-resistant epilepsy. Details: A small clinical study in adults and adolescents aged 12 years or older with drug-resistant epilepsy shows that adjunctive treatment with MCTs (Stepan Lipid Nutrition) as part of a non-ketogenic diet, 47-65 mL daily (about 35% of energy intake), or a maximally tolerated dose not exceeding 100 mL, for 12 weeks reduces median seizure frequency by 46% when compared with baseline (101967). The validity of this study is limited by its small sample size and the lack of a comparator group.
• Gallbladder disease. Although there has been interest in using oral MCTs for gallbladder disease, there is insufficient reliable information about the clinical effects of MCTs for this purpose.
• Hypertriglyceridemia. Oral MCTs might improve triglyceride levels and body weight in some patients with overweight and hypertriglyceridemia, but its effect in other populations is unclear. Details: Clinical research in patients with overweight and hypertriglyceridemia shows that taking 25-30 grams of an oil containing MCTs 13% daily for 8 weeks decreases triglyceride levels by 78 mg/dL when compared with consuming oil containing only long chain fats. Body weight, body fat, and waist circumference also decreased (93740). However, this benefit may be restricted to this specific population only. Some research in patients with obesity or patients with a normal body weight shows that taking 25-30 grams of an oil containing MCTs daily for 8 weeks does not lower triglyceride levels (93741).
• Obesity. Small clinical studies suggest that oral MCTs modestly improves weight loss; however, any effects may not be clinically relevant. Details: A meta-analysis of clinical research shows that taking MCTs decreases body weight by 0.5 kg, waist circumference by 1.5 cm, and hip circumference by 0.8 cm when compared with a control group not taking MCTs. Doses used in available research have ranged from 1-54 grams daily, or 1% to 24% of energy for 4-16 weeks (93735). Most research shows that at least 4 weeks is needed before effects are seen. The greatest benefit seems to occur in patients of Asian descent, males, and patients with higher body mass indices at baseline (93730,93731,93735,93736). While MCTs may improve weight loss in some patients, the effects are generally modest and may not be clinically relevant.
• Prematurity. It is unclear if oral or topical MCTs are beneficial in preterm infants. Details: A meta-analysis of small studies involving 136 otherwise healthy preterm infants receiving full enteral diets with formula as the predominant source of nutrition shows that administration of formulas containing at least 30% of fat by weight as MCTs (ranging in concentration from 6% to 80%) for at least 7 days does not affect short-term growth, including weight, length, and head circumference, when compared with formulas containing less than 30% of fat by weight as MCTs. Due to small study sizes, it is unclear whether either type of formula was better tolerated. The validity of this analysis is limited by the presence of unclear risk of potential bias in the included studies (105711). MCT oil has also been evaluated for the prevention of gastrointestinal Candida infections. A very small clinical study in preterm infants shows that adding MCT oil (Nestlé Health Science) 0.5 mL per ounce of formula or breast milk for 1 week reduces Candida colonization when compared with no MCT oil (101968). Topical use of MCT oil has also been evaluated for growth in preterm infants. A small clinical study in preterm infants weighing 1500-2000 grams shows that massage with MCT oil, consisting of tactile and kinesthetic stimulation, three times daily for 7 days increases weight gain when compared with no massage (107739). The validity of this finding is limited by unclear reporting. Also, it is unclear if this effect is due to MCT oil, massage, or the combination.
• Primary intestinal lymphangiectasia. It is unclear if oral MCTs are beneficial for the management of primary intestinal lymphangiectasia. Details: A review of 55 case reports suggests that taking MCTs as part of a low-fat, high-protein diet resolves symptoms in 63% of patients with primary intestinal lymphangiectasia, compared with 36% of patients receiving no treatment or other treatments such as diuretic therapy, albumin transfusions, resection of isolated segments of affected bowels, etc. Mortality is also reduced by 79% in patients treated with diet restrictions and MCTs when compared with those receiving no treatment or other treatments (93733).
• Sarcopenia. It is unclear if oral MCTs are beneficial in frail older adults. Details: A small clinical study in older adults residing in a nursing home shows that taking MCTs 6 grams, leucine 1.2 grams, and vitamin D (cholecalciferol) 20 mcg daily for 3 months increases body weight by 1.1 kg, right-hand grip strength by 13%, and peak expiratory flow by 28% when compared with baseline. These improvements are also significant when compared with patients receiving no supplementation (93729). In a second study in this same population conducted by the same research group, taking MCTs 6 grams, with or without leucine 1.2 grams and vitamin D (cholecalciferol) 20 mcg, daily for 3 months does not increase body weight or hand grip strength. There were small to moderate improvements in opening and closing the legs, repetitive swallowing, and measures of functional independence (101970). The validity of these findings is limited by the single-blind nature of the studies and the large number of endpoints. It is also unclear if any benefits are due to MCTs, other ingredients, or the combination.
• Short bowel syndrome. Although there has been interest in using oral MCTs for short bowel syndrome, there is insufficient reliable information about the clinical effects of MCTs for this purpose. More evidence is needed to rate MCTs for these uses.

(Read more about MEDIUM CHAIN TRIGLYCERIDES (MCTs))

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyspepsia. Oral olive leaf extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing olive leaf extract 24% and prickly pear cactus 33% (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Exercise-induced respiratory infections. It is unclear if oral olive leaf extract is beneficial for reducing respiratory infections from exercise. Details: A small clinical study in high school athletes shows that taking one tablet of olive leaf extract providing eleuropein 100 mg daily for 2 months during training season does not reduce the incidence of the common cold when compared with placebo. While it may reduce the number of sick days by 28%, a sub-group analysis suggests that this reduction is only evident in female athletes (101860).
• Gastroesophageal reflux disease (GERD). Although there is interest in using oral olive leaf for GERD, there is insufficient reliable information about the clinical effects of olive for this condition.
• Herpes zoster (shingles). Although there is interest in using oral olive leaf for shingles, there is insufficient reliable information about the clinical effects of olive for this condition.
• Influenza. Although there is interest in using oral olive leaf for influenza, there is insufficient reliable information about the clinical effects of olive for this condition.
• Metabolic syndrome. It is unclear if oral olive leaf extract is beneficial for improving body composition and cardiovascular risk factors in patients with metabolic syndrome. Details: A small clinical trial in overweight, middle-aged males at risk for metabolic syndrome shows that taking four capsules of olive leaf extract providing oleuropein 51.1 mg and hydroxytyrosol 9.7 mg daily for 12 weeks improves insulin sensitivity by 15% when compared with placebo. However, body composition, blood pressure, cholesterol levels, and other cardiovascular risk factors were not improved (92245).
• Osteoarthritis. It is unclear if oral olive fruit or leaf extract is beneficial for improving osteoarthritis. Details: Preliminary clinical research shows that taking a freeze-dried aqueous extract of olive fruit 400 mg daily for 8 weeks decreases pain and increases mobility in people with osteoarthritis (14844). Other preliminary clinical research in adults with knee osteoarthritis shows that taking olive leaf extract 50.1 mg daily for 4 weeks improves overall pain measurements by 14%, compared to only 4% in the placebo group. However, many individual measurements of pain are not improved (92252).
• Osteoporosis. It is unclear if oral olive leaf extract is beneficial for osteoporosis. Details: Clinical research shows that taking olive leaf extract (Bonolive, BioActor BV) 250 mg daily for 12 months, along with elemental calcium 400 mg daily, increases osteocalcin levels by about 32% when compared to baseline; this increase was significant when compared to those taking calcium 400 mg plus placebo, who showed a 6% decrease in osteocalcin levels. However, taking olive leaf extract does not significantly increase bone mineral density of the lumbar spine or femur neck when compared with placebo (92247).
• Rheumatoid arthritis (RA). It is unclear if oral olive fruit extract is beneficial for improving RA symptoms. Details: Preliminary clinical research in adults with RA shows that taking an aqueous freeze-dried extract of olive fruit 400 mg daily for 8 weeks does not improve symptoms when compared with control (14844). More evidence is needed to rate the effectiveness of olive for these uses.

(Read more about OLIVE)

POSSIBLY EFFECTIVE

• Food allergies. Clinical research in infants 1 month of age and older with IgE-mediated allergy to cow's milk protein shows that administering either a partially hydrolyzed rice protein formula supplemented with lysine and threonine or a hydrolyzed cow's milk formula until age 24 months results in similar overall growth. Hydrolyzed rice protein formula is also similarly effective to hydrolyzed cow's milk formula for improving the rate of tolerance to cow's milk (97798).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Exercise-induced muscle soreness. Preliminary clinical research shows that taking rice protein isolate (Oryzatein rice protein, Axiom Foods) 48 grams in water immediately after resistance training three times weekly for 8 weeks is as effective for reducing muscle soreness and increasing perceived recovery as taking whey protein isolate 48 hours after each individual session (95674). The validity of this finding is limited by the lack of a placebo comparator group.
• Muscle strength. Preliminary clinical research shows that taking rice protein isolate (Oryzatein rice protein, Axiom Foods) 48 grams in water immediately after resistance training three times weekly for 8 weeks is as effective for increasing muscle mass and muscle strength as taking whey protein isolate 48 hours after each individual session (95674). The validity of this finding is limited by the lack of a placebo comparator group.

(Read more about RICE PROTEIN)

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.

(Read more about SODIUM)

POSSIBLY EFFECTIVE

• Constipation. Taking xanthan gum orally as a bulk-forming laxative seems to decrease constipation (4917,4918).
• Swallowing dysfunction. Using a specific xanthan gum product (Resource ThickenUp Clear, Nestle Health Science) as a thickener in liquid feeds improves swallowing and reduces the risk of aspiration in people with swallowing dysfunction similarly to a modified starch thickener (Resource ThickenUp, Nestle Health Science). Xanthan gum also does not appear to leave the pharyngeal residues seen with the modified starch product (100912,100913).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Taking xanthan gum 12 grams orally daily in muffins seems to lower blood glucose in people with diabetes (4916).
• Dry eye. Using eye drops containing xanthan gum and chondroitin sulfate (PRO-148 or Xiel ofteno, Sophia Laboratories) four times daily for 60 days improves tear film break-up times, ocular surface disease index, and symptoms of dry eye similarly to polyethylene glycol/propylene glycol eye drops (Systane, Alcon Laboratories Inc.) (89591,95794). It is not clear if this effect is due to xanthan gum, chondroitin sulfate, or the combination.
• Sjogren syndrome. Applying xanthan gum topically in the mouth seems to help as a saliva substitute in people with Sjogren syndrome (4915).

(Read more about XANTHAN GUM)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Beta-glucans derived from oat bran, baker's yeast, or brewer's yeast (Saccharomyces cerevisiae) have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately, short-term in medicinal amounts. There is some evidence that yeast-derived beta-glucans 15 grams daily can be used safely for up to 8 weeks (7272). Oat-derived beta-glucans 3-10 grams daily can also be used safely for up to 12 weeks (7272,5796,17129,34700,34727,34729,34765,34766,34811,34812)(34876,107935,109206). ...when used topically and appropriately. A specific beta-glucans serum and emulsion (Awake; Hangzhou Songyang Biotechnical) combination has been used with apparent safely for up to 12 weeks in clinical research (109210). A specific beta-glucans cream (Imunoglukan P4H, PLEURAN s.r.o.) has been used with apparent safety 2-3 times daily for up to 6 months (98201).

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

(Read more about BETA-GLUCANS)

LIKELY SAFE ...when used orally and appropriately. Guar gum has been safely used in doses up to 15 grams daily for up to two years (10326,10897,12541,12543,12544,12548,54212,54245,54260,54275)(54333,93617,93619,93622,101888). Doses up to 20 grams daily have been safely used for up to 51 weeks (10896,12545,12547,54314). Guar gum has Generally Recognized as Safe (GRAS) status as a food additive in the US (4912).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. Guar gum has been safely used in doses of 4-5 grams daily for 4 weeks in children 6-16 years of age (93605,93615). Guar gum 3 grams daily for 4 weeks has been safely used in children 4-6 years of age (93605).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts. Guar gum has been safely used at doses of 5-15 grams daily for up to 4 weeks during pregnancy (54209,54356).

LACTATION:
There is insufficient reliable information available about the safety of using medicinal amounts of guar gum during lactation; avoid using.

(Read more about GUAR GUM)

LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Gum arabic has Generally Recognized As Safe (GRAS) status for use in foods in the US. It is also considered to be safe for use as a food additive by the European Food Safety Authority (4912,105040).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (8072). Up to 30 grams daily of powdered gum arabic has been used with apparent safety for 3 months (18237,99098,105040).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in foods (4912,105040).

(Read more about GUM ARABIC)

LIKELY SAFE ...when used orally and appropriately (11726,11727,11728,11729,11730,93729). ...when used parenterally and appropriately (2275,2276,2278,11726,11727,11728,11729). There is insufficient reliable information available about the safety of MCTs when used topically.

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

(Read more about MEDIUM CHAIN TRIGLYCERIDES (MCTs))

LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.

POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.

(Read more about OLIVE)

POSSIBLY SAFE ...when rice protein is consumed in food. Rice protein has generally recognized as safe (GRAS) status in the United States for use in food products at concentrations of up to 34.3% (97812). ...when hydrolyzed rice protein is used topically on the hair and skin. The Cosmetic Ingredient Review Expert Panel has concluded that hydrolyzed rice protein is safe for use in cosmetic ingredients based on cutaneous tolerance testing in individuals with non-sensitive skin (97802).

CHILDREN: POSSIBLY SAFE
when hydrolyzed rice protein with additional lysine and threonine is used in infant formula as the sole source of nutrition in infants less than 6 months of age, and then as part of the diet until 24 months of age. However, hydrolyzed protein formulas are only recommended for use in infants unable to tolerate cow's milk or other proteins. Breast milk or standard formula is recommended for most infants (97794,97795,97798,97799). Rice is a source of inorganic arsenic, which is known to negatively impact long-term health. The amount of inorganic arsenic in rice protein products or hydrolyzed rice protein-based formulas is not known. Look for products that declare the inorganic arsenic content and provide information regarding its potential risk (97793).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in food.

(Read more about RICE PROTEIN)

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).

(Read more about SODIUM)

LIKELY SAFE ...when consumed in amounts found in foods, up to 10 mg/kg per day (4914). It has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used orally for medicinal use in amounts up to 15 grams per day (4914,4916,4917,4918). ...when used topically and appropriately (4914,89591,95794).

PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using in amounts greater than those found in foods.

(Read more about XANTHAN GUM)

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking beta-glucans with antihypertensive drugs might increase the risk of hypotension.  Details Clinical research shows that taking beta-glucans may reduce systolic and diastolic blood pressure in some hypertensive individuals (34684,34691,34722).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, beta-glucans might interfere with immunosuppressive therapy.  Details Some clinical research shows that beta-glucans have immunostimulant effects (34809,34860,34879,92659,103886,105264).

(Read more about BETA-GLUCANS)

DIGOXIN (Lanoxin) Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = B Guar gum might slow digoxin absorption, but it does not seem to impact how much digoxin is absorbed overall.  Details Two small studies in healthy volunteers show no change in the overall extent of digoxin absorption, although early absorption was slowed, when taken with guar gum (533,25074).

ETHINYL ESTRADIOL Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, guar gum might reduce the absorption of ethinyl estradiol, potentially decreasing its effectiveness.  Details Animal research shows that taking guar gum with ethinyl estradiol decreases ethinyl estradiol absorption (12421). However, this effect has not been reported in humans.

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Guar gum might reduce the absorption of metformin, potentially decreasing its effectiveness.  Details A small study in healthy volunteers shows that guar gum reduces the absorption rate of metformin (532,12546).

ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Guar gum might reduce the absorption of some oral drugs, potentially decreasing their effectiveness.  Details Clinical research shows that guar gum reduces or slows absorption of medications such as penicillin and metformin (532,533). To avoid changes in absorption, take guar gum 30-60 minutes after oral medications.

PENICILLIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Guar gum might reduce the absorption of penicillin, potentially decreasing its effectiveness.  Details A small clinical study in healthy volunteers shows that taking guar gum with penicillin results in decreased penicillin absorption and reduced penicillin levels (533).

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AMOXICILLIN (Amoxil, Trimox) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Gum arabic can reduce the absorption of amoxicillin.  Details A small study in healthy volunteers shows that taking amoxicillin and gum arabic concurrently significantly reduces the absorption of amoxicillin. Separate doses of amoxicillin from gum arabic by at least 2 hours (12654).

ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, gum arabic can alter the absorption of oral drugs due to its fiber content.  Details Gum arabic has been used as a suspending osmotic agent in drug formulations. It might improve bioavailability of water-insoluble drugs like naproxen, but reduce absorption of polar drugs like amoxicillin (12654,104058). To avoid changes in absorption, take gum arabic 30-60 minutes after oral medications.

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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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General ...Orally and topically, beta-glucans seem to be well-tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis, skin reactions.

Dermatologic ...Topically, a specific beta-glucans cream r.o.) has been reported to cause skin reactions and contact dermatitis in one clinical trial. These reactions occurred in 27% of patients; reactions were mild and self-limiting in 12% of patients (98201).

Hematologic ...In one clinical trial of children and young adults with neuroblastoma, one of 44 patients developed transient elevations of aspartate transaminase and alanine transaminase within five days of starting oral beta-glucans 120 mg/kg daily (109203).

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General ...Orally, guar gum is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, bloating, diarrhea, flatulence, heartburn, gas, and loose stools.
Serious Adverse Effects (Rare):
Orally: Severe esophageal and small bowel obstruction when taken with an inadequate amount of fluid.

Gastrointestinal ...Orally, guar gum may cause gastrointestinal adverse effects such as abdominal cramps, abdominal pain, bloating, diarrhea, flatulence, heartburn, gas, and loose stools (10896,10897,12541,12543,12545,12547,12548,54209,54212,54232)(54260,54314,54333,93617,93619). Gastrointestinal side effects can be minimized by starting with small doses and titrating up. In one clinical study, taste aversion to guar gum leading to withdrawal from the study has been reported (16736).
When guar gum is consumed with inadequate amounts of fluids, it can cause severe esophageal and small bowel obstruction. Tell patients to take guar gum with at least 8 ounces (250 mL) of water (602,54230).

Pulmonary/Respiratory ...Occupational exposure to guar gum may cause asthma (600,601).

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General ...Orally, gum arabic seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal bloating, flatulence, mild diarrhea, nausea, and vomiting.

Gastrointestinal ...Orally, gum arabic can cause minor gastrointestinal disturbances such as abdominal bloating, flatulence, nausea, vomiting, cramping, and mild diarrhea (8072,18237,99098,105038,105040,108051). These effects occurred in 15%, 82%, and 90% of subjects respectively in one study (18237). They may subside with continued use within 2 weeks (8072,18237,99098,105038).

Immunologic ...Gum arabic might cause allergic reactions. In one case report, a patient had an immunoglobulin E response after exposure to gum arabic. However, there have been no identified case reports of allergic reactions after oral exposure to gum arabic (19636,105040).

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General ...Orally, MCTs can cause significant gastrointestinal upset, especially with higher doses.
Most Common Adverse Effects:
Abdominal discomfort, diarrhea, essential fatty acid deficiency, intestinal gas noises, irritability, nausea, reflux, vomiting. Gastrointestinal disturbances are thought to be associated with higher doses of MCT. Since MCTs are fats, excessive consumption can result in weight gain.

Cardiovascular ...There is some concern that MCTs may further increase the risk for hypertriglyceridemia in some preterm infants due to immature lipoprotein lipase activity in these infants. A case of extremely elevated triglyceride levels of 4,736 mg/dL and associated lipemia retinalis has been reported at 43 weeks post-menstrual age (PMA) for a preterm infant born at 30 weeks' gestational age. It was discovered that the baby had been receiving MCT supplements in addition to breast milk starting at 42 weeks' PMA. MCT supplements were discontinued. One month later triglycerides were reduced to 287 mg/dL, and the retinal vasculature had a normal hue. However, at 2-month follow-up, triglyceride levels were elevated to levels higher than normal for age despite MCT discontinuation. Investigators speculated that a genetic disorder of lipid metabolism may also have contributed to the elevated triglyceride levels in addition to use of MCTs (96330).

Gastrointestinal ...Orally, MCTs can cause significant gastrointestinal upset. Diarrhea is the most commonly reported side effect (11723,93737,93738,101967). Other reported side effects include vomiting, irritability, nausea, reflux, abdominal discomfort, intestinal gas noises, and essential fatty acid deficiency (11723,93738,101967). Taking MCTs with food can reduce these adverse effects (93737). Gastrointestinal disturbances are thought to be associated with higher doses of MCT, such as 85 grams (93731).

Other ...Excessive consumption of MCTs can result in weight gain. MCT oil contains 6-8.5 calories per gram. One tablespoon provides about 14 grams and about 115 calories (11724).

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General ...Orally, olive fruit is well tolerated when used in typical food amounts. Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.

Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).

Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).

Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).

Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).

Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).

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General ...Orally, rice protein seems to be generally well tolerated. Enterocolitis associated with rice protein has been rarely reported in young children (97806,97811). Although rice protein is considered hypoallergenic, allergies to the proteins in rice have been reported when used topically and orally (97802,97806,97811).

Dermatologic ...The Cosmetic Ingredient Review Expert Panel has concluded that hydrolyzed rice protein is safe for use in cosmetic ingredients based on cutaneous tolerance testing in individuals with non-sensitive skin (97802). However, topical application of undiluted hydrolyzed rice protein has been rarely reported to cause redness (97802).

Gastrointestinal ...Orally, rice protein has been rarely reported to cause enterocolitis symptoms of vomiting, diarrhea, and dehydration, possibly leading to acidosis and lethargy, in infants and young children (97806,97811). Rarely, enterocolitis symptoms are associated with an allergy to rice protein (97806,97811).

Immunologic ...Orally, rice protein has been rarely reported to cause enterocolitis. These symptoms have been possibly associated with an allergy to rice protein (97806,97811). In one case report of allergic enterocolitis, boiling did not adequately degrade the proteins involved in the IgE-mediated response. However, processing at high temperatures in a retort pouch allowed for adequate degradation (97806).
Hydrolysis of rice protein with enzymatic decomposition, typically used for oral consumption, reduces dermatologic allergic symptoms in most people (97802).

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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, xanthan gum can cause flatulence and abdominal distention (4916,4918). Topically, it has been reported to cause allergic reactions (100914).

Immunologic ...An itchy, burning dermatitis was reported in a 9-year old girl after application of a sunscreen product containing xanthan gum. Patch testing with the separate ingredients of the sunscreen identified xanthan gum as the reacting agent, and demonstrated a dose-dependent effect with 1% and 10% solutions (100914).

Pulmonary/Respiratory ...Occupational exposure in workers handling xanthan gum powder can cause flu-like symptoms and nose and throat irritation without acute or chronic loss of pulmonary function (4913).

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