Coconut Mango Fruit & Nut Bar by VegiDay

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dementia. It is unclear if consuming dewaxed brown rice improves cognitive function in adults with dementia. Details: A small clinical study in elderly nursing home residents with low cognitive function shows that eating dewaxed brown rice with 3 meals daily for 6 months improves scores on the Revised Hasegawa's Dementia Scale to a greater extent than eating white rice (103626).
• Diabetes. It is unclear if consuming brown rice as part of the diet is beneficial for improving glycemic control in adults with type 2 diabetes; the available research is conflicting. Details: Meta-analyses of clinical trials evaluating adults with type 2 diabetes shows that consuming a diet containing brown rice 50-450 grams daily for 4-104 weeks does not improve glycated hemoglobin (HbA1c) levels or fasting blood glucose levels when compared with a white rice diet (108661,108662). Clinical trials using non-glutinous brown rice for 24 hours or 16 weeks show similar results (96996,96998). However, not all research agrees. Preliminary clinical research in adults with type 2 diabetes shows that eating glutinous brown rice twice daily for 8 weeks modestly reduces HbA1c levels, compared with no change in those eating white rice (96995). Preliminary clinical research also shows that eating glutinous brown rice as the staple food over a 24-hour period helps with acute glycemic response when compared with white rice (96996). Other preliminary clinical research in females with type 2 diabetes shows that following a brown rice diet for 12 weeks reduces HbA1c and fasting blood glucose by 3% to 5% and reduces body weight and body fat by approximately 2% when compared with no intervention (18660). Clinical trials in adults with type 2 diabetes also report conflicting effects of brown rice on body weight, waist circumference, body fat, lipids, and blood pressure when compared with white rice (108661,108662). However, the limited studies showing positive benefits of brown rice report very minor effects with unclear clinical implications. The reasons for these discrepancies are unclear but may be related to the slight differences between the varieties of brown rice.
• Impaired glucose tolerance (Prediabetes). It is unclear if consuming brown rice as part of the diet is beneficial for improving glycemic control; the available research is conflicting. Details: A meta-analysis of clinical trials evaluating adults with prediabetes shows that consuming a brown rice-based diet for 6-12 weeks does not improve glycated hemoglobin (HbA1c) levels, fasting blood glucose levels, body weight, or waist circumference when compared with a white rice-based diet (108662). However, some preliminary clinical research in middle-aged females with prediabetes shows that replacing staple white rice in the diet with pre-germinated brown rice for 4 months modestly reduces fasting blood glucose and HbA1c levels when compared with baseline. There were also small improvements in body fat, body mass, systolic and diastolic blood pressure, and total cholesterol levels when compared with baseline (96997). The validity of these findings is limited by the lack of a comparator group.
• Metabolic syndrome. It is unclear if consuming brown rice reduces the prevalence of metabolic syndrome or improves metabolic parameters in patients with this condition. Details: Preliminary clinical research in adults with metabolic syndrome shows that eating brown rice ad libitum for 16 weeks does not improve metabolic factors or reduce the number of patients still meeting the diagnosis of metabolic syndrome when compared with eating white rice ad libitum (96998). However, other clinical research shows that eating 200 grams daily of cooked, pre-germinated brown rice for 3 months reduces the number of patients meeting the diagnosis of metabolic syndrome by 30%, compared with a reduction of 10% in those eating 200 grams daily of cooked white rice (103627). This suggests that any benefit might be related to regular consumption of brown rice. A small clinical study in overweight adults with metabolic syndrome shows that eating brown rice with 2 meals per day, 6 days per week for 3 months, reduces glycated hemoglobin (HbA1c) when compared with eating the same amount of white rice (103623). Other preliminary clinical research shows that eating sticky or glutinous brown rice for 8 weeks modestly improves body weight, some measures of insulin resistance, and levels of low-density lipoprotein (LDL) cholesterol when compared with baseline (96999). The validity of these findings is limited by the lack of a comparator group.
• Obesity. Although there is interest in using oral brown rice for weight loss, there is insufficient reliable information about the clinical effects of brown rice for this purpose.
• Psoriasis. Although there is interest in using oral brown rice for psoriasis, there is insufficient reliable information about the clinical effects of brown rice for this condition. More evidence is needed to rate brown rice for these uses.

(Read more about BROWN RICE)

POSSIBLY INEFFECTIVE

• Hyperlipidemia. A meta-analysis of small clinical studies suggests that consuming chia seeds, flour, powder, or oil for 7-24 weeks does not improve lipid levels in patients with conditions associated with hyperlipidemia. Details: A meta-analysis of 10 small clinical trials in patients with various metabolic conditions, including diabetes, metabolic syndrome, nonalcoholic fatty liver disease, and obesity, shows that consuming chia seeds, flour, or powder 15-60 grams daily for 7-24 weeks, or taking chia oil 6 grams daily for 8 weeks, does not reduce total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglyceride levels or increase high-density lipoprotein (HDL) cholesterol levels when compared with control groups consuming wheat bran, oat bran, dietary fiber, poppy seeds, or soybean oil (106657). While the patient populations in the studies analyzed are more likely to develop hyperlipidemia, it is unclear if these findings can be generalized to patients diagnosed with hyperlipidemia.
• Obesity. Small clinical studies suggest that consuming chia seeds for up to 12 weeks does not reduce body weight in overweight or obese adults. Details: One small clinical study in overweight or obese individuals shows that ingesting chia seeds 25 grams mixed in 0.25 liters of water twice daily before meals for 12 weeks does not improve body composition or reduce blood pressure when compared with placebo (25533). Another small clinical study in overweight, postmenopausal females shows that ingesting milled or whole chia seeds 25 grams daily for 10 weeks does not improve body composition or blood pressure when compared to baseline (25532).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. It is unclear if oral chia is beneficial for improving athletic performance. Details: A small clinical study in trained athletes shows that drinking a beverage containing 50% of calories from chia seeds (Greens Plus Omega 3 Chia seeds) and 50% of calories from a carbohydrate-containing beverage (Gatorade) for 2 days prior to participating in an endurance exercise lasting more than 90 minutes leads to similar performance when compared with Gatorade alone (25531).
• Cardiovascular disease (CVD). Although there has been interest in using oral chia for CVD, there is insufficient reliable information about the clinical effects of chia for this purpose.
• Diabetes. Small clinical studies suggest that consuming chia for 4-6 months might reduce systolic blood pressure (SBP) in patients with type 2 diabetes, although it does not appear to improve glycemic control or lipid levels and has shown mixed effects on body weight and inflammatory markers. Details: One small clinical trial in patients with type 2 diabetes shows that consuming bread containing a specific, selectively bred type of chia (Salba, Salba Smart Natural Products LLC), providing 37 grams of chia daily for 12 weeks reduces SBP, C-reactive protein, and vonWillebrand factor, but not lipid levels, when compared with consuming bread containing wheat bran. This form of chia also significantly reduced glycated hemoglobin (HbA1c) when compared to baseline, but not when compared with a wheat bran control (16124). Another small clinical study in adults with type 2 diabetes and obesity shows that consuming Salba chia 40 grams daily, either baked into bread or as a powder, in conjunction with a restricted calorie diet for 6 months reduces weight by 1.6 kg and waist circumference by 2.8 cm when compared with an oat bran control. However, consuming chia had no effect on body fat percentage, HbA1c, or fasting glucose levels (97940). Also, a small clinical study in adults with type 2 diabetes shows that consuming chia seeds 40 grams daily for 12 weeks reduces SBP, but does not improve body weight, HbA1c, or levels of fasting glucose, lipids, or C-reactive protein, when compared with those not consuming chia (106658).
• Hypertension. It is unclear if oral chia is beneficial in patients with hypertension. Details: A very small clinical study in patients with mild hypertension shows that consuming chia flour 35 grams daily for 12 weeks reduces systolic blood pressure (SBP) by around 10 mm Hg and diastolic blood pressure (DBP) by almost 9 mm Hg when compared to baseline. In patients already taking antihypertensive drugs, chia seems to have an even greater impact on SBP and DBP. However, in patients not being treated with antihypertensive drugs, chia flour modestly reduces SBP by 6.5%, but does not significantly reduce DBP. No improvements in blood pressure were reported in patients consuming a wheat bran control (91516).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral chia is beneficial in patients with NAFLD. Details: Small, uncontrolled clinical studies in patients with NAFLD show that consuming milled chia seeds 25 grams daily for 8 weeks may reduce hepatic steatosis, as measured by the liver: spleen attenuation ratio, in up to 43% of subjects with prediabetes and 100% of subjects with diabetes when compared to baseline. Chia seed supplementation may also modestly reduce visceral fat, body mass index, and waist circumference in patients with prediabetes when compared to baseline, but does not seem to improve lipid levels (104530,110438). The validity of these findings is limited by the lack of a comparator group in both studies.
• Metabolic syndrome. Oral chia has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with metabolic syndrome shows that reducing daily caloric intake by 500 kcal and drinking a beverage containing chia seed 4 grams, soy protein 32 grams, dehydrated nopal 7 grams, and oat 22 grams daily for 2 months reduces body weight, body mass index, and waist circumference when compared to baseline, but not when compared with following a reduced calorie diet alone. However, following the reduced calorie diet and drinking this beverage appears to lower serum triglycerides and C-reactive protein and improve glucose tolerance when compared with a reduced calorie diet alone (25534). It is unclear if these findings are due to chia, other ingredients, or the combination.
• Muscle strength. It is unclear if oral chia is beneficial for increasing muscle strength and muscle mass during resistance training. Details: A very small clinical trial in healthy, non-resistance trained males shows that drinking a supplemental beverage containing chia flour 50 grams, providing 20 grams of protein and 3 grams of omega-3 fatty acids, is no more effective than whey protein 20 grams or placebo for augmenting the increases in muscle strength and fat-free mass that occur with an 8-week whole body resistance training program (112385). The habitual baseline diet of the study participants already contained dietary protein intakes recommended for strength training, and the beverage was only consumed three times per week immediately after training sessions.
• Pruritus. It is unclear if topical chia seed oil is beneficial in patients with pruritus. Details: One very small, uncontrolled clinical study in patients with xerotic pruritus or pruritus caused by kidney failure or diabetes shows that applying lotion containing chia seed oil 4% for 8 weeks improves skin hydration and reduces the severity of lichen simplex chronicus and prurigo nodularis when compared to baseline (25537). The validity of these findings is limited by the small study size and lack of a comparator group. More evidence is needed to rate chia for these uses.

(Read more about CHIA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Although there is interest in using oral coconut for diabetes, there is insufficient reliable information about the clinical effects of coconut for this condition.
• Hypercholesterolemia. It is unclear if oral coconut is beneficial for lowering cholesterol levels; the available research is conflicting. Details: Preliminary clinical research in patients with moderately elevated serum cholesterol levels shows that consuming corn flakes with 15% or 25% dietary fiber from coconut flakes (prepared with coconut flour) for 2 weeks reduces total cholesterol by about 7% to 11% and low-density lipoprotein (LDL) cholesterol by about 9% to 11% when compared with baseline (26295). However, population research suggests that people who consume large amounts of coconut have higher cholesterol levels when compared with those who do not (26558). These conflicting results may be due to the type of coconut being consumed. For example, coconut contains coconut oil, which has been associated with increased cholesterol levels in some research (12361,17940). On the other hand, coconut flour is prepared from coconut residue after extraction of milk; this byproduct residue is defatted and contains a high percentage of water-soluble dietary fiber (26197).
• Lichen Planus. There is limited evidence on the use of topical coconut cream in adults with oral lichen planus. Details: Preliminary clinical research findings suggest that topical coconut 50% cream may reduce lesion size, burning sensation, and pain level over a time period of 60 days when compared with baseline. Coconut cream appears to be similarly effective to the standard treatment clobetasol propionate 0.05% ointment in the treatment of oral lichen planus. The study is limited by unclear statistical analysis, small sample size, and a short follow-up period (110713).
• Obesity. Although there is interest in using oral coconut for weight loss, there is insufficient reliable information about the clinical effects of coconut for this condition. More evidence is needed to rate coconut for these uses.

(Read more about COCONUT)

LIKELY EFFECTIVE

• Constipation. Rectal glycerol is beneficial in children and adults with constipation. Details: Glycerol rectal suppositories and enemas are approved by the US Food and Drug Administration (FDA) for over-the-counter use to treat occasional constipation in adults and children at least 2 years of age (15).

POSSIBLY EFFECTIVE

• Athletic performance. Oral glycerol may improve hydration during exercise, but clinical studies evaluating glycerol for improving measures of athletic performance are limited and conflicting. Details: Several clinical studies show that glycerol increases serum osmolality and improves hydration status during exercise (2475,2476,93757,93760,93761,93765). One meta-analysis, including 14 studies and 99 patients, shows that glycerol-induced hyperhydration increases body water by approximately 2.5-fold when compared with water-induced hyperhydration (93757). Also, taking glycerol along with table salt 7.5 grams per liter fluid seems to improve hydration status when compared withg glycerol alone (99162). Research regarding the effects of glycerol on thirst, comfort, temperature regulation, sweating, and heart rate is conflicting (2475,2476,93760,99162). While glycerol may improve hydration status during exercise, it is unclear whether it can improve measures of athletic performance. An early meta-analysis including a total of 36 athletes shows that taking glycerol increases endurance performance by 2.6%. Although this is a small difference, it might be considered meaningful to athletes (93757). Some small clinical studies in athletes suggest that glycerol increases endurance and time to exhaustion, with no effect on heat regulation (2475,2479,93764). However, other small studies suggest that glycerol does not reduce perceived exhaustion or improve exercise performance (2476,93760). Also, glycerol has not been shown to increase time to exhaustion in triathletes (2492). When used to improve athletic performance, glycerol is most often taken at doses of 1-1.5 gram/kg in conjunction with approximately 1.5 L of fluid, 60-120 minutes before competition, and in some cases continued during the competition (2475,93757,93760,93764).
• Ichthyosis. Topical application of a specific product containing glycerol and paraffin may improve symptoms of ichthyosis in children. The benefits of topical glycerol alone in these patients is unknown. Details: A large clinical trial in children aged 1 month to 18 years shows that applying a specific product (Dexeryl, Pierre Fabre Laboratoires) containing glycerol 15% and paraffin 10% for 4 weeks reduces symptoms of non-bullous ichthyosis by at least 50% in an additional 17% of children when compared with a placebo cream. Applying this specific product also improves pruritus by an additional 45% when compared with placebo (93756). It is unclear if these findings are due to glycerol, paraffin, or the combination.

POSSIBLY INEFFECTIVE

• Meningitis. Some clinical research suggests that oral glycerol does not reduce the risk of mortality or seizures in adults and children with bacterial meningitis, although it may reduce certain sequelae. Details: A meta-analysis of five low-quality clinical trials including 1,270 patients shows that adjunctive treatment with glycerol as an oral osmotic agent does not reduce the risk of mortality, seizures, or gastrointestinal symptoms in adults and children with acute bacterial meningitis, although it may modestly reduce the risk of deafness and residual neurological deficit in surviving children (99160). Clinical research included in the meta-analysis has used glycerol 1.5 grams/kg every 6 hours in children aged 2 months to 16 years (93762,93763).
• Prematurity. Rectal glycerol does not appear to reduce the time to enteral feeding in premature infants. Details: Glycerol is used as an enema or given by suppository to facilitate the evacuation of meconium in premature infants in order to reduce the time to enteral feeding. However, two meta-analyses of small studies in preterm infants, that include some of the same studies, show that administering glycerol suppositories does not reduce the number of days to full enteral feeds when compared with placebo or no treatment (99166,112003). However, the interpretation of these findings is limited by the heterogeneity of dosages used in the included studies.

LIKELY INEFFECTIVE

• Stroke. Intravenous glycerol may not improve mortality or symptoms in patients with acute ischemic stroke. Details: Several clinical studies show that intravenous administration of glycerol does not improve symptoms of acute stroke (2480,2481,2482,2484,2486). Additionally, one clinical study in elderly patients with acute ischemic stroke shows that while glycerol can improve initial survival, it does not reduce the risk of overall mortality when compared with placebo (2483).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dandruff. Topical glycerol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical trial in adults with dandruff shows that applying a leave-in hair lotion containing glycerol 10%, stearic acid 2.5%, and sunflower seed oil 0.6%, 3 times weekly for 8 weeks, modestly reduces dandruff severity throughout use and for up to one week after the last application when compared with a placebo lotion. The glycerol lotion also reduced total water loss from the scalp by 8% and increased moisturization by 23% (93758). It is unclear if these findings are due to glycerol, other ingredients, or the combination.
• Dry skin. Topical glycerol has only been evaluated in combination with other ingredients for the management of dry skin associated with kidney failure; its effect when used alone is unclear. Details: One small, open-label clinical study in adults with kidney failure and moderate to severe uremic xerosis shows that applying an emulsion containing glycerol 15% and paraffin 10% twice daily for 7 days reduces the severity of xerosis when compared with a placebo emulsion. The glycerol-containing emulsion produces a treatment response in an additional 29% of patients, improves quality of life, and reduces scale density and thickness when compared with placebo (93754). It is unclear if these findings are due to glycerol, paraffin, or the combination.
• Glaucoma. Although there has been interest in using oral glycerol for glaucoma, there is insufficient reliable information about the clinical effects of glycerol for this purpose.
• Intracranial hypertension. Although there has been interest in using intravenous glycerol to reduce intracranial pressure in patients with brain tumors, central nervous system (CNS) trauma, encephalitis, idiopathic intracranial hypertension, meningitis, and Reye syndrome, there is insufficient reliable information about the clinical effects of glycerol for this purpose.
• Meniere disease. It is unclear if intravenous glycerol is beneficial in patients with Meniere disease. Details: A small, uncontrolled clinical study in adults with unilateral, intractable Meniere disease shows that intravenous administration of glycerol 10% at a dose of 0.5 grams/kg once daily for 2 consecutive days, twice monthly for 6 months, reduces the frequency of vertigo attacks and improves quality of life when compared to baseline. Patients reported an average of 3.2 vertigo attacks per month at baseline and 1.2 vertigo attacks per month after 6 months of treatment (106649). The lack of a control group limits the validity of these findings.
• Neonatal jaundice. It is unclear if rectal glycerol improves jaundice-related outcomes in premature infants. Details: A small clinical study in neonates receiving phototherapy for jaundice shows that administering glycerol suppositories has no effect on the duration of phototherapy needed for jaundice treatment, or on bilirubin levels or the rate of bilirubin decline when compared with no glycerol suppositories (99165).
• Obesity. It is unclear if oral glycerol is beneficial in patients who are overweight or obese. Details: One small clinical study in adults on a low-calorie diet shows that taking glycerol 7.5 grams before meals for 6 weeks does not increase weight loss when compared with placebo (2485).
• Otitis externa. Topical glycerol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in adults with otitis externa shows that inserting ribbon gauze soaked in glycerol and ichthammol into the ear canal reduces pain and swelling as effectively as the application of antibiotic and steroid drops three times daily (93759). It is unclear if these findings are due to glycerol, ichthammol, or the combination. More evidence is needed to rate glycerol for these uses.

(Read more about GLYCEROL)

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)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Obesity. Preliminary clinical research in healthy overweight males shows that consuming a bread providing quinoa flour 20 grams daily for 4 weeks does not affect anthropometric measures, blood pressure, or plasma levels of glucose or cholesterol when compared with consuming a refined wheat bread (99147).
• Postmenopausal conditions. One small clinical study in postmenopausal adults shows that consuming quinoa flakes 25 grams daily for 4 weeks does not improve glycemic or lipid indices or anthropometric measures when compared with consuming corn flakes (99148). More evidence is needed to rate quinoa for these uses.

(Read more about QUINOA)

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)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Brown rice has Generally Recognized as Safe (GRAS) status in the US (7705). There is insufficient reliable information available about the safety of brown rice when used orally in medicinal amounts.

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in food. Brown rice has Generally Recognized as Safe (GRAS) status in the US (7705). There is insufficient reliable information available about the safety of brown rice when used in medicinal amounts in children.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (7705). There is insufficient reliable information available about the safety of brown rice when used in medicinal amounts during pregnancy or lactation.

(Read more about BROWN RICE)

LIKELY SAFE ...when used orally in amounts commonly found in foods (104531,104532).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Chia has been used safely at doses up to 40 grams daily for up to 6 months (16124,97940). ...when used topically, short-term. A product containing chia seed oil 4% has been applied to the skin safely for up to 8 weeks (25537).

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

(Read more about CHIA)

LIKELY SAFE ...when used orally in food amounts. Coconut is recognized as safe for human consumption by the US Food and Drug Administration (95809).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Corn flakes supplemented with 15% or 25% dietary fiber from coconut flakes prepared with coconut flour have been used with apparent safety (26295).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (95809). There is insufficient reliable information available about the safety of coconut when used in medicinal amounts during pregnancy and lactation; avoid use.

(Read more about COCONUT)

LIKELY SAFE ...when used rectally and appropriately. Glycerol rectal suppositories and enemas are approved by the US Food and Drug Administration (FDA) for over-the-counter use to treat occasional constipation (15,272). ...when used topically and appropriately as a lotion, emulsion, or humectant (15,272,93754,93758,93759,99164).

POSSIBLY SAFE ...when used orally, short-term. Glycerol has been used with apparent safety in clinical trials at doses of up to 1.5 grams/kg (2474,2475,99162).

POSSIBLY UNSAFE ...when used intravenously. While some research suggests that intravenous glycerol can be safely administered for two consecutive days twice monthly for up to 6 months (106649), in another study, hemolysis was reported in 98% of patients treated with intravenous glycerol for acute ischemic stroke (2482).

CHILDREN: LIKELY SAFE
when used rectally and appropriately. Glycerol rectal suppositories and enemas are approved by the US FDA for over-the-counter use to treat occasional constipation in children 2 years of age and older (15,272). ...when used topically and appropriately as an emulsion or humectant in children 1 month of age and older (15,272,93756).

CHILDREN: POSSIBLY SAFE
when used orally, short-term. Glycerol has been used with apparent safety in clinical trials in children 2 months to 16 years of age at doses of 1.5 gram/kg, up to a maximum dose of 25 grams, taken every 6 hours (93762,93763).

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

(Read more about GLYCEROL)

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)

LIKELY SAFE ...when used orally in food amounts. Quinoa is a common food source for many people (99147,99148,99149). There is insufficient reliable information available about the safety of quinoa when used in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts. There is insufficient reliable information available about the safety of quinoa in medicinal amounts; avoid using.

(Read more about QUINOA)

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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ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking coconut with antidiabetes drugs might increase the risk of hypoglycemia.  Details Animal research suggests that coconut milk might increase insulin levels and/or decrease blood glucose levels (107671).

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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, brown rice is well tolerated when consumed as a food. No adverse effects have been reported when used in medicinal amounts; however, a thorough evaluation of safety outcomes has not been conducted.

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General ...Orally and topically, chia seems to be well tolerated.
Most Common Adverse Effects:
Orally: Flatulence and soft stools.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.

Cardiovascular ...Chia contains a high concentration of alpha-linolenic acid (ALA). There is some concern that ALA might increase triglyceride levels more than other omega-3 fatty acids (12918); however, clinical research with a specific variety of chia called Salba shows that it does not significantly increase triglyceride levels (16124).

Gastrointestinal ...Orally, chia might cause mild gastrointestinal adverse effects. Some patients consuming chia 40 grams daily for up to 6 months reported mild and transient gastrointestinal adverse effects such as flatulence and soft stools; however, the frequency of these adverse effects was similar to patients consuming an oat bran control (97940). Bloating and flatulence have been reported with a chia flour-based sports beverage (112385).

Immunologic ...Orally, chia might cause anaphylaxis in sensitive individuals. A single case of IgE-mediated anaphylactic reaction has been reported for a patient who consumed chia seeds. Symptoms, including pruritus in the mouth, urticaria, facial angioedema, shortness of breath, and dizziness, developed a few days after consuming chia seeds. The reaction was attributed to sensitivity to proteins in chia seeds (91517).

Oncologic ...Chia seeds contain a high concentration of alpha-linolenic acid (ALA). Epidemiologic research suggests that high dietary intake of ALA might increase risk for prostate cancer (1337,2558,7823,7147,12978). Other research suggests high intake or serum levels of ALA does not increase the overall risk of prostate cancer (12961,15736); however, it might increase the risk of advanced prostate cancer (12961). Association with prostate cancer appears to depend on the sources of ALA. Dairy and meat sources have been positively associated with prostate cancer, whereas plant sources, such as chia seed, don't seem to affect prostate cancer risk (12909). According to a clinical trial, intake of ALA does not appear to increase levels of prostate specific antigen (PSA) (91402).

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General ...Orally, coconut is generally well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions, including anaphylaxis and hives.

Dermatologic ...Orally or topically, coconut and coconut palm pollen may cause allergic skin reactions such as urticaria and hives (12359,26561,26572,95806).

Immunologic ...Although coconut is a stone fruit, in the US, coconut is grouped with tree nuts for allergen declaration purposes (107673). Orally or topically, coconut can cause allergic reactions ranging from hives to anaphylaxis in those with hypersensitivity to coconut or its pollen (12359,26561,95806,95807,95808,107673,107674). Based on a review of hospital records in the US, most reactions to coconut are due to oral exposure, including through breastfeeding, with about 50% of reactions associated with anaphylaxis (107673). In addition, there have been numerous case reports of anaphylaxis from coconut in the literature, with most cases presenting in infancy or early childhood (95808,107674). In one case report, a 12-year-old child with asthma and allergic rhinitis experienced anaphylaxis with difficulty breathing, wheezing and vomiting, from eating a piece of coconut for the first time (95808). In another case report, a 6-year-old child who had previously had urticaria and hives from applying coconut oil experienced throat swelling and anaphylaxis after eating food containing coconut (95806). Coconut may also play a role in cross-sensitization. In a case report, a 17-year-old male who experienced prickling in the mouth after ingesting coconut soon after experienced an anaphylactic reaction to buckwheat. The child was found to be sensitized to both coconut and buckwheat (95807).

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General ...Orally, rectally, and topically, glycerol seems to be well tolerated. Intravenously, glycerol may be unsafe.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, nausea, vomiting, dizziness, and headache.
Topically: Burning, irritation, and pruritus.
Intravenously: Hemolysis in patients with acute ischemic stroke.

Dermatologic ...Topically, glycerol has been reported to cause burning, irritation, and pruritus (93754,93756). Rectally, the regular administration of glycerol 50% enemas has been reported to cause generalized urticaria in at least two patients; in both patients, symptoms resolved after discontinuation (110019,110025).

Gastrointestinal ...Orally, glycerol can cause bloating, nausea, vomiting, thirst, and diarrhea (15,2475).

Hematologic ...Intravenously, glycerol has been reported to caused hemolysis in people treated for acute ischemic stroke (2480,2482).

Neurologic/CNS ...Orally, glycerol can cause mild headache and dizziness (15,2475).

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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, quinoa seems to be well-tolerated. Rarely, quinoa can cause allergic reaction in some individuals, including anaphylaxis (99150,99151,96062).

Immunologic ...Orally, allergic reactions to quinoa have been reported (99150,96062). Anaphylaxis and pruritic reactions have occurred in at least two individuals, a 29-year-old female and a 52-year-old male. Quinoa allergy was confirmed in both patients via skin-prick testing with quinoa extract (99150,99151).

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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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