Acai Natural Juice Blend by The Vitamin Shoppe

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there is interest in using oral or topical acai to prevent aging skin, there is insufficient reliable information about the clinical effects of acai for this purpose.
• Athletic performance. It is unclear if oral acai is beneficial for improving athletic performance. Details: Preliminary clinical research in amateur cyclists shows that consuming 400 grams of pasteurized acai pulp daily for 15 days prevents oxidative damage and decreases levels of blood lactate during exercise by 28% when compared with placebo. Consuming acai pulp also seems to increase anaerobic threshold intensity, but does not improve maximum workload or measures of exertion, when compared to baseline (102860).
• Erectile dysfunction (ED). Although there is interest in using oral acai for ED, there is insufficient reliable information about the clinical effects of acai for this condition.
• Hypercholesterolemia. Although there is interest in using oral acai for hypercholesterolemia, there is insufficient reliable information about the clinical effects of acai for this condition.
• Metabolic syndrome. Although there is interest in using oral acai for metabolic syndrome, there is insufficient reliable information about the clinical effects of acai for this condition.
• Obesity. It is unclear if oral black seed is beneficial for improving metabolic indices in overweight individuals. Details: In overweight individuals, preliminary clinical research shows that consuming 100 mg of acai pulp (Sambazon Acai Smoothie Pack, Sambazon Inc.) twice daily for one month reduces fasting glucose and total cholesterol levels when compared with baseline. However, no effect was seen on levels of low density lipoprotein (LDL) cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol, or blood pressure (17731). The validity of these findings is limited by the lack of a comparator group.
• Osteoarthritis. Although there is interest in using oral acai for osteoarthritis, there is insufficient reliable information about the clinical effects of acai for this condition.
• Tinnitus. It is unclear if oral acai is beneficial for chronic tinnitus. Details: A small clinical study in adults with unilateral or bilateral chronic tinnitus, with either normal hearing or mild hearing loss, shows that taking dried acai pulp extract 100 mg daily for 3 months decreases tinnitus discomfort when compared with baseline (107846). However, the validity of this finding is limited by the lack of statistical comparison to the placebo group, which reported a numerically similar improvement in tinnitus discomfort. More evidence is needed to rate acai for these uses.

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POSSIBLY INEFFECTIVE

• Hypertension. Most clinical research suggests that consuming freeze-dried blueberries or blueberry powder does not lower blood pressure in patients with hypertension, prehypertension, or other risk factors for cardiovascular disease. Details: Although conflicting results exist (92386,99139), a meta-analysis of 6 clinical trials including approximately 200 patients with hypertension, prehypertension, or other risk factors for cardiovascular disease shows that consuming freeze dried blueberries or blueberry powder 22-50 grams daily for 6-8 weeks does not significantly lower systolic or diastolic blood pressure when compared with placebo (92390).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. It is unclear if oral blueberry can improve symptoms of anxiety. Details: A small clinical study in healthy adults shows that drinking 30 mL of blueberry juice diluted in 100 mL of water twice daily for 20 days reduces measures of state and trait anxiety when compared with placebo (111235).
• Age-related cognitive decline. Small clinical studies suggest that oral blueberry products may slightly improve some measures of cognitive function in older adults with age-related cognitive decline. Details: Most clinical evidence shows that blueberry can improve some aspects of cognitive decline, but it has minimal effect on other measures. One small clinical trial in older patients with self-reported cognitive decline shows that taking freeze-dried blueberry powder 12.5 grams twice daily for 6 months modestly improves cognitive performance in daily activities but most measures of cognitive function did not improve (97181). Another small clinical study in patients 60 years of age and older with self-reported memory complaints shows that taking a wild blueberry extract (ThinkBlue, Naturex Inc) 100 mg daily with cysteine and glutathione modestly improves episodic memory at 3 months, but not at 6 months, when compared with placebo. However, taking this same blueberry extract or a wild blueberry powder 450 mg or 900 mg daily with cysteine and glutathione does not improve sequence recall, working memory, or executive function (99139). Other small clinical studies show a benefit in some, but not all measures of executive functioning and memory (96467,111234)
• Aging. It is unclear if consuming blueberry can improve functional mobility in adults 60 years of age and older. Details: One small clinical study in adults over 60 years of age shows that consuming 2 cups of frozen blueberries daily for 6 weeks improves some measures of functional mobility, such as foot placement and balance, when compared with drinking carrot juice. However, blueberry does not seem to improve hand grip strength, executive function, or other measurements of gait speed when compared with carrot juice (92387). Another small clinical study in this same age group shows that consuming 12 grams of powdered blueberry mixed with liquid twice daily for 3 months does not improve measures of functional mobility when compared with placebo (96467).
• Athletic performance. Small clinical studies suggest that oral freeze-dried blueberry powder may not reduce exertion or improve long-distance running performance in trained runners. Details: Two small clinical studies in adults with running experience show that taking freeze-dried blueberry powder 24 grams three times daily for four days does not improve perceived exertion, the time to run 8 km, or distance run over 30 minutes when compared with placebo. However, blueberry does appear to modestly attenuate increases in blood lactate after running (101963,107282).
• Cancer. Although there has been interest in using oral blueberry for preventing cancer, there is insufficient reliable information about the clinical effects of blueberry for this purpose.
• Cardiovascular disease (CVD). Small clinical studies suggest that oral blueberry supplementation might modestly improve body weight and triglyceride levels, but not body mass index (BMI), glycemic control, or cholesterol levels, in patients at risk for CVD. Details: A meta-analysis of 11 small and low-quality clinical studies involving a total of 497 adults with various risk factors for CVD shows that taking blueberry for 4-16 weeks modestly reduces weight and triglyceride levels, but does not improve other risk factors for CVD, including BMI, glycemic indices, cholesterol levels, and certain inflammatory mediators, when compared with placebo or other control. In a sub-group analysis, weight reduction was slightly more favorable in studies of longer than 6 weeks' duration (mean reduction of 0.91 kg) and in studies using blueberry powder or freeze-dried blueberry (mean reduction of 0.86 kg) (105702). The validity of these findings is limited by the heterogeneity and small size of the included studies. Additionally, it is unclear if blueberry is beneficial for reducing the risk for CVD or CVD-related complications.
• Cataracts. Although there has been interest in using oral blueberry for preventing cataracts, there is insufficient reliable information about the clinical effects of blueberry for this purpose.
• Cognitive function. Small clinical studies suggest that oral blueberry products may improve some, but not most, measures of cognitive function in children and adults. Details: Several small clinical studies in children 7-10 years of age show that drinking a blueberry drink containing 30 grams of freeze-dried blueberries or 200 grams of fresh blueberries as a single dose does not improve most measures of cognitive function when compared with placebo. These trials showed small improvements in some measures of cognitive function, including auditory-verbal learning, word recognition, and delayed memory, but these specific findings were not consistent across all studies (92394,96465,101961). Additionally, a small clinical trial in healthy young adults shows that taking a combination of blueberry and grape extracts (Memophenol, Activ'Inside) 600 mg increases the ability to complete serial three subtraction by 2.5-fold when compared with placebo. However, there were no other improvements in working memory or attention during a sustained cognitive effort (101960).
• Depression. It is unclear if oral blueberry extract or freeze-dried powder is beneficial in patients with depression. Details: One small clinical study in adults with cerebral venous thrombosis (CVT)-associated depression and depression-associated gastrointestinal infection shows that taking blueberry extract 10 mg daily for 3 months reduces symptoms of depression by 49% and gastrointestinal infection rates by 84% when compared to baseline; when compared with placebo, these changes are significant (96464). Another small clinical study in healthy adults shows that drinking 30 mL of blueberry juice diluted in 100 mL of water twice daily for 20 days reduces symptoms of depression when compared with placebo (111235). A small clinical study in healthy adolescents 11-17 years of age without diagnosed mental health issues at baseline shows that drinking freeze-dried wild blueberry powder 13 grams daily for 4 weeks improves self-reported depressive symptoms, but not anxiety symptoms or transient affect, when compared with placebo. The adolescents enrolled in this study were found to have suboptimal fruit and vegetable intake at baseline (105703).
• Diabetes. It is unclear if oral freeze-dried blueberry powder is beneficial in patients with diabetes. Details: A small clinical study in males 45-75 years of age with type 2 diabetes shows that drinking 11 grams of freeze-dried highbush blueberry powder mixed with water twice daily with a meal for 8 weeks reduces glycated hemoglobin (HbA1c) values and triglyceride levels, but not body weight, fasting plasma glucose, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, or blood pressure, when compared with placebo. This study may have been inadequately powered to detect a difference between groups (105701). Blueberry has also been evaluated for the prevention of gestational diabetes. A small clinical study in patients with a history of gestational diabetes shows that consuming 280 grams of blueberries plus 12 grams of soluble fiber daily for 18 weeks, starting at less than 20 weeks' gestation, along with standard care reduces maternal weight gain and blood glucose levels after glucose challenge testing when compared with standard care alone. However, neither gestational diabetes incidence nor infant birth weight was lower with blueberry supplementation when compared with standard care alone (107281).
• Hyperlipidemia. It is unclear if oral blueberry is beneficial in patients with hyperlipidemia. Details: One small clinical study in healthy adults shows that drinking blueberry juice 30 mL twice daily for 20 days reduces total cholesterol and low-density lipoprotein (LDL) cholesterol when compared with placebo (111235). Additionally, drinking a combination of blueberry, apple, chokeberry, and cranberry juice 300 mL daily for 6 weeks appears to decrease total cholesterol and increase high-density lipoprotein (HDL) cholesterol when compared to baseline in females with overweight or obesity and at least one risk factor for cardiovascular disease (111233). However, the validity of the study is limited by its small size, short duration, and lack of a comparator group. It is unclear if these effects are due to blueberry, other ingredients, or the combination. In contrast, other small clinical studies suggest that blueberry does not improve lipid levels (105701,111234). A small clinical study in males 45-75 years old shows that blueberry has no effect on total cholesterol, HDL cholesterol, and LDL cholesterol, but may reduce triglycerides, when compared with placebo. However, in a sub-group of patients also taking lipid-lowering medications, blueberry reduced levels of total cholesterol and LDL cholesterol when compared with placebo (105701). Another small clinical study in middle-aged adults with overweight shows that taking oral blueberry powder daily for 12 weeks does not impact total cholesterol, LDL cholesterol, HDL cholesterol, or triglycerides when compared with placebo (111234). However, these studies may have been inadequately powered to detect a difference between groups.
• Hypertriglyceridemia. It is unclear if oral blueberry leaf extract is beneficial in patients with hypertriglyceridemia. Details: A small clinical trial in patients with mild to moderate hypertriglyceridemia shows that taking a single dose of a blueberry leaf extract 300 mg along with a high-fat meal reduces postprandial triglyceride levels, but not postprandial glucose or insulin levels, when compared with placebo (101959).
• Juvenile idiopathic arthritis (JIA). It is unclear if oral blueberry juice is beneficial in children with JIA. Details: A small clinical study in children with JIA shows that adding 50 mL of blueberry juice daily to treatment with etanercept 50 mg twice weekly for 6 months increases the percentage of patients who achieve a 20% improvement in symptoms based on American College of Rheumatology criteria when compared with taking etanercept along with placebo juice. About 75% of patients in the blueberry juice group experienced a 20% improvement in symptoms, compared with 51% of patients in the placebo group, suggesting that for every four patients that drink blueberry juice along with etanercept therapy, one additional patient will experience a 20% or greater improvement in symptoms. Drinking blueberry juice also appears to reduce side effects caused by etanercept, including weight gain, infection, diarrhea, and anorexia (92388).
• Metabolic syndrome. Small clinical studies in patients with metabolic syndrome, along with an analysis of studies in patients at risk for metabolic syndrome, suggest that oral freeze-dried blueberries do not improve body weight or glycemic control, but may slightly lower blood pressure and cholesterol levels. Details: A small clinical study in patients with metabolic syndrome shows that taking freeze-dried blueberry powder 26 grams daily for 6 months improves flow-mediated dilation by 45% when compared with placebo, but does not affect low-density lipoprotein (LDL) cholesterol levels, insulin resistance, or blood pressure. In a sub-group of patients not taking statins, blueberry increased levels of high-density lipoprotein (HDL) cholesterol by 3 mg/dL; however, a lower dose of 13 grams daily had no beneficial effects (101958). Another small clinical trial in patients with metabolic syndrome shows that consuming freeze-dried blueberries 25 grams twice daily for 8 weeks reduces systolic blood pressure by around 4% and diastolic blood pressure by around 3% when compared with placebo, but does not affect body weight, lipid levels, or glycemic control (107278). Additionally, a small clinical trial in patients with metabolic syndrome shows that drinking a smoothie containing freeze-dried blueberry powder 22.5 grams twice daily for 6 weeks does not improve blood pressure, body weight, glycemic control, or lipid levels when compared with placebo, although it does improve measures of endothelial function (107279). A meta-analysis evaluating the studies above, along with 9 small clinical trials in patients at risk for metabolic syndrome, shows that blueberry supplementation does not improve body weight, glycemic control, triglyceride levels, or systolic blood pressure. However, it reduces total cholesterol by around 8 mg/dL, low-density lipoprotein (LDL) cholesterol by around 9 mg/dL, and diastolic blood pressure by around 2 mmHg when compared with placebo (107280).
• Muscle strength. Oral blueberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in young, healthy males shows that taking blueberry extract 200 mg plus phosphocreatine disodium salts 5 grams daily for 28 days improves peak torque and average power during leg extension exercises when compared to baseline, while individuals taking placebo saw no improvements in these measures (107284). It is unclear if these findings are due to blueberry, phosphocreatine, or the combination.
• Night vision. Although there has been interest in using oral blueberry for improving night vision, there is insufficient reliable information about the clinical effects of blueberry for this purpose.
• Obesity. Oral blueberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in females with overweight or obesity and at least one risk factor for cardiovascular disease shows that drinking a combination of blueberry, apple, chokeberry, and cranberry juice 300 mL daily for 6 weeks does not reduce body weight, body mass index (BMI), or blood pressure but might improve total cholesterol and high-density lipoprotein (HDL) cholesterol when compared to baseline (111233). However, the validity of these findings is limited by the small study size, short duration, and lack of a comparator group. It is unclear if these effects are due to blueberry, other ingredients, or the combination.
• Urinary tract infections (UTIs). Although there has been interest in using oral blueberry for preventing UTIs, there is insufficient reliable information about the clinical effects of blueberry for this purpose. More evidence is needed to rate blueberry for these uses.

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POSSIBLY EFFECTIVE

• Hypertension. Oral pomegranate juice seems to modestly reduce blood pressure. Details: Most clinical research evaluating pomegranate juice for reducing systolic blood pressure (SBP) and diastolic blood pressure (DBP) shows modest benefits (8310,13023,13691,69372,69373,69374). A meta-analysis of results from eight clinical studies including 574 patients shows that pomegranate juice reduces SBP by about 5 mmHg, but does not affect DBP, when compared with placebo. Doses of pomegranate juice ranged from 43-330 mL daily for 2 weeks to 18 months. Changes in SBP and DBP were not related to the dose or duration of pomegranate juice consumption (96247).

POSSIBLY INEFFECTIVE

• Diabetes. Most oral pomegranate products do not seem to be beneficial for diabetes. It is unclear if pomegranate seed powder is beneficial. Details: A meta-analysis of clinical research shows that taking pomegranate has no effect on glycated hemoglobin (HbA1c) or plasma levels of insulin, lipids, or fasting glucose when compared with placebo in patients with type 2 diabetes. Various formulations, including juice, fruit extract, peel extract, and seed oil, were used in these studies (105265). However, a more recent clinical trial shows that drinking a beverage twice daily for 8 weeks, made by soaking a 'tea bag' containing pomegranate seed powder 5 grams in hot water for 10 minutes, modestly reduces levels of fasting blood glucose, HbA1c, total cholesterol, and triglycerides when compared with placebo. Fasting blood glucose levels were reduced by approximately 4%, compared with a 6% increase in the placebo group (105270).
• Hyperlipidemia. Oral pomegranate does not seem to be beneficial for hyperlipidemia. Details: Most clinical research shows that taking pomegranate does not increase high-density lipoprotein (HDL) cholesterol levels or reduce total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglyceride levels when compared with placebo (13022,13023,13690,69142,69168,69276). A meta-analysis of results from 12 clinical studies including 545 patients with or without hyperlipidemia shows that taking pomegranate daily for at least 10 days and up to 1 year does not improve blood lipid levels when compared with placebo. Pomegranate formulations evaluated in these studies include juice, seed oil, whole fruit, extract, and vinegar beverage; no specific form or dose of pomegranate was associated with improvements in cholesterol or triglyceride levels (96248). One preliminary clinical study has evaluated pomegranate juice in combination with other fruits. Results from the study show that taking a specific pomegranate-containing combination product (Radical Fruits, Garden of Life) 900 mg orally three times daily before meals reduces total and LDL cholesterol and increases HDL cholesterol in males with hypercholesterolemia (69170). However, it is unclear if these benefits are due to pomegranate, other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. It is unclear if oral pomegranate juice is beneficial for preventing atherosclerosis. Details: Preliminary clinical research shows that drinking pomegranate juice 50 mL daily reduces intima-media thickness of the carotid artery by up to 35% after one year when compared to baseline in patients with atherosclerosis and carotid artery stenosis (13023).
• Athletic performance. It is unclear if oral pomegranate extract is beneficial for athletic performance. Details: Preliminary clinical research in trained male cyclists shows that taking pomegranate extract (POM Wonderful LLC) 15 mg/kg daily for 8 days moderately reduces the amount of oxygen needed to perform submaximal exercise when compared with placebo. However, pomegranate extract does not improve performance in a timed trial (99100). Other preliminary clinical research in regionally competitive male cyclists shows that taking pomegranate extract (Pomanox P30, Euromed S.A.) 750 mg daily for 15 days increases the time to exhaustion by 94 seconds after a prolonged submaximal effort, as well as the time to reach the anaerobic threshold by about 55 seconds, when compared with placebo. There was no effect on the restoration of force or on oxygen consumption (101881).
• Chronic obstructive pulmonary disease (COPD). It is unclear if oral pomegranate juice is beneficial for COPD. Details: A small clinical trial shows that drinking pomegranate juice 400 mL daily for 5 weeks does not improve symptoms or respiratory function in patients with COPD when compared with placebo (13692).
• Coronary heart disease (CHD). It is unclear if oral pomegranate juice is beneficial for patients with CHD. Details: Some preliminary clinical research shows that drinking pomegranate juice (POM Wonderful Pomegranate Juice, POM Wonderful LLC) 240 mL daily for 3 months decreases stress-induced myocardial ischemia in patients with CHD. The average improvement in myocardial perfusion was about 17% with pomegranate juice, compared with an 18% worsening of myocardial perfusion in patients taking placebo (13691). However, other preliminary clinical research in patients with moderate CHD risk shows that drinking the same pomegranate juice product 240 mL daily for 18 months does not improve carotid intima-media thickness when compared to control (17329). It is not known if drinking pomegranate juice can prevent or reduce the risk of a myocardial infarction or other cardiovascular outcomes.
• Dental plaque. It is unclear if rinsing the mouth with pomegranate extract is beneficial for reducing dental plaque. Details: Preliminary clinical research shows that rinsing with pomegranate extract mouthwash for one minute once or twice daily reduces dental plaque in patients with or without fixed orthodontic appliances. The antiplaque activity of pomegranate extract is similar to that of chlorhexidine (69171,69316).
• Erectile dysfunction (ED). It is unclear if oral pomegranate juice is beneficial for ED. Details: In patients with mild-to-moderate ED, preliminary clinical research shows that drinking pomegranate juice daily for 4 weeks does not improve symptoms of ED when compared with placebo (69175).
• Exercise-induced muscle soreness. It is unclear if oral pomegranate juice is beneficial for reducing exercise-induced muscle soreness. Details: Preliminary clinical research shows that drinking pomegranate juice (POM Wonderful Pomegranate Juice, POM Wonderful LLC) 250 mL twice daily for 15 days reduces post-exercise muscle soreness in elbow flexor, but not knee extensor, muscles in resistance-rained males when compared with placebo (69355). However, in non-resistance trained males, drinking the same pomegranate juice 250 mL twice daily for 9 days does not reduce exercise-induced muscle damage or delayed onset soreness of elbow flexor muscles when compared with placebo (101880).
• HIV/AIDS. Although there has been interest in using oral pomegranate for HIV/AIDS, there is insufficient reliable information about the clinical effects of pomegranate for this condition.
• Influenza. Although there has been interest in using oral pomegranate for influenza prevention, there is insufficient reliable information about the clinical effects of pomegranate for this purpose.
• Intrauterine growth restriction (IUGR). It is unclear if oral pomegranate juice is beneficial for preventing brain injury in IUGR neonates. Details: In patients with an IUGR pregnancy, clinical research shows that drinking pomegranate juice 8 ounces daily from 24-34 weeks' gestation until delivery reduces the risk of an MRI-diagnosed gray matter brain injury in the infant by approximately 28%. There was no effect on brain volume or white matter injury (105267).
• Kidney failure. It is unclear if oral pomegranate juice is beneficial for patients on hemodialysis; the available research is conflicting. Details: Some preliminary clinical research shows that taking pomegranate juice (Nutrafood) 100 mL during the first dialysis treatment hour three times weekly for one year reduces antihypertensive medication requirements and the rate of second hospitalization due to infection when compared with placebo. Consuming pomegranate juice also increases high-density lipoprotein (HDL) cholesterol in patients with baseline levels of 40 mg/dL or less and reduces triglycerides in patients with baseline levels of at least 200 mg/dL (91698,91699). Preliminary clinical research also shows that taking pomegranate juice 100 mL immediately after dialysis three times weekly for 8 weeks reduces triglycerides by approximately 20%, as well as systolic and diastolic blood pressure by 5% and 7%, respectively, when compared with baseline. HDL cholesterol was also increased by approximately 23%. These changes were significant when compared with placebo (101882). However, pomegranate juice did not affect total cholesterol, low-density lipoprotein (LDL) cholesterol, liver enzymes, or incidence of cardiovascular events when compared with placebo (91698,91699,101882). Other preliminary clinical research shows that drinking pomegranate juice (POM Wonderful Pomegranate Juice, POM Wonderful LLC) 100 mL or taking pomegranate juice extract tablets (POM Wonderful LLC) 1050 mg daily prior to each dialysis session for 4 weeks does not improve blood pressure, lipids, or markers of inflammation and oxidative stress when compared to baseline in patients receiving maintenance hemodialysis (91697). Although the reason for these conflicting findings is not clear, it may have to do with the timing of consumption. The evidence suggests that offering pomegranate during dialysis or after completion of dialysis might be more effective than prior to dialysis.
• Menopausal symptoms. It is unclear if oral pomegranate seed oil or pomegranate extract is beneficial for menopausal symptoms. Details: Preliminary clinical research shows that taking a specific pomegranate seed oil (Delima, Pekana Naturheilmittel GmbH) 30 mg orally twice daily for 12 weeks does not reduce the frequency of hot flashes when compared with placebo in postmenopausal adults experiencing at least 5 hot flashes per day. However, pomegranate seed oil might improve sleep in some patients with sleep disturbances attributed to menopause (91685). A clinical study in healthy, perimenopausal and menopausal adults with untreated menopausal symptoms shows that taking pomegranate extract 3 mL three times daily for 4 weeks reduces symptoms, including hot flashes and vertigo, and improves physical and mental quality of life when compared with placebo. Additionally, these improvements were sustained 3 weeks after discontinuing treatment (108484). The validity of this study is limited by the short duration of treatment.
• Metabolic syndrome. It is unclear if oral pomegranate juice is beneficial for metabolic syndrome. Details: Preliminary clinical research shows that drinking pomegranate juice 240 mL daily for one month improves endothelial dysfunction in adolescents with metabolic syndrome when compared with drinking grape juice 240 mL daily (53174,69362).
• Muscle strength. It is unclear if oral pomegranate juice is beneficial for increasing muscle strength. Details: Preliminary clinical research shows that taking a specific pomegranate extract (POMx, POM Wonderful LLC) 480 mL twice daily modestly improves recovery of strength 2-3 days after eccentric exercise but does not reduce muscle soreness after exercise when compared with placebo (69261).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral pomegranate seed oil or pomegranate extract improves anthropometric measures in adults with NAFLD. Details: A small clinical study in overweight and obese adults with NAFLD shows that taking a dried pomegranate extract, standardized to contain 90 mg of ellagic acid, twice daily for 12 weeks reduces body mass index and body weight when compared with placebo. A 5 kg weight reduction occurred in the pomegranate group, compared to a small increase in weight in the placebo group. Pomegranate also improved diastolic blood pressure, as well as lipid and glycemic parameters; however, the patients included in this study had normal baseline parameters, limiting the validity of this finding (108481). Pomegranate has also been evaluated in combination with other ingredients. One small clinical crossover study in obese females with NAFLD shows that taking a specific combination product (Xanthigen, Polinat) containing pomegranate seed oil 300 mg and brown marine algae 300 mg (standardized to fucoxanthin 2.4 mg) modestly reduces body weight and liver fat content when compared with placebo (69257).
• Obesity. It is unclear if oral pomegranate is beneficial for obesity. Most evidence suggests that it is not beneficial, although some studies have yielded conflicting findings. Details: A meta-analysis of 513 participants shows that taking pomegranate extract, juice, or concentrate for 2-26 weeks does not reduce body weight, body mass index, waist circumference, or body fat percentage when compared with placebo or other control (101883). However, most of these studies were not designed to investigate weight as the primary outcome, and some preliminary clinical research in overweight or obese individuals suggests that some pomegranate products might have some benefit. Drinking pomegranate juice 120 mL daily for one month helps these individuals maintain weight when compared with placebo, although it does not appear to improve glucose, insulin secretion, or insulin sensitivity (91693).
• Oropharyngeal candidiasis. It is unclear if topical pomegranate peel extract is beneficial for oropharyngeal candidiasis. Details: Preliminary clinical research in patients with candidiasis associated with denture stomatitis shows that applying a gel containing the extract of pomegranate fruit peel to the gums three times daily for 15 days seems to be as effective as miconazole gel for improving symptoms of candidiasis (13689).
• Polycystic ovary syndrome (PCOS). It is unclear if oral pomegranate juice is beneficial for PCOS. Details: In patients with PCOS, preliminary clinical research shows that taking pomegranate juice 45 mL daily for 8 weeks reduces systolic and diastolic blood pressures by 10 and 4 mmHg, respectively, when compared with a control group not taking pomegranate juice. Triglyceride and high-density lipoprotein (HDL) cholesterol levels were also modestly improved. However, there was no effect on glycemic measures, and low-density lipoprotein (LDL) cholesterol levels increased by 6 mg/dL (105266). Another clinical trial in patients with PCOS shows that taking synbiotic pomegranate juice containing inulin and lactobacillus as 2 liters weekly for 8 weeks improves insulin sensitivity, body mass index, waist circumference, and testosterone levels when compared with baseline or a control juice. However, patients consuming a drink containing only the synbiotic ingredients experienced the same improvements, whereas patients consuming only regular pomegranate juice experienced no benefits, suggesting that pomegranate was not responsible for these changes (101884).
• Prostate cancer. It is unclear if oral pomegranate extract or juice is beneficial for prostate cancer. Details: Preliminary clinical research shows that pomegranate might slow prostate cancer progression in some patients after surgery or radiation for prostate cancer. The length of time to doubling of prostate specific antigen (PSA) was longer in those who took a specific pomegranate extract (POMx, POM Wonderful LLC) 1-3 grams daily, as well as those who drank 8 ounces of pomegranate juice daily, for up to 24 months (14137,14388,91695). However, the results from a large well-designed study do not support these findings. This study shows that taking 8 ounces of a pomegranate liquid extract does not increase the length of time to doubling of PSA (105271). In patients with favorable-risk localized prostate cancer, a small clinical trial also shows that taking pomegranate fruit extract (POMx, POM Wonderful) 1000 mg daily for 12 months does not affect the length of time to doubling of PSA, although there were some changes in tumor markers of DNA damage (105269). Pomegranate has also been evaluated in combination with other ingredients. Preliminary clinical research in patients with localized prostate cancer shows that taking a combination supplement containing pomegranate powder 100 mg, broccoli powder 100 mg, turmeric powder 100 mg, and green tea extract 20 mg daily for 6 months slows the increase in PSA levels when compared with placebo (89730). It is not clear if this effect is due to pomegranate, the other ingredients, or the combination.
• Rheumatoid arthritis (RA). It is unclear if oral pomegranate extract is beneficial for RA. Details: Preliminary clinical research shows that taking a specific pomegranate extract (POMx, POM Wonderful LLC) 5 mL twice daily for 12 weeks decreases disease activity and reduces tender joint count by 62% when compared to baseline in patients with RA (91686). The validity of these findings is limited by the lack of a control group.
• Rhinosinusitis. It is unclear if intranasal pomegranate extract is beneficial for chronic rhinosinusitis. Details: A clinical study in adults with chronic rhinosinusitis or rhinitis persisting longer than 12 weeks, with or without the presence of nasal polyps, shows that using a nasal spray containing pomegranate extract in an unknown dose twice daily for 30 days does not improve objective or subjective nasal or sinus symptoms when compared with placebo nasal spray. In a subgroup of patients with chronic rhinitis, including allergic and nonallergic rhinitis, improvement in thick nasal discharge is also observed in those receiving the pomegranate nasal spray; however, the study does not report outcomes for each subtype of rhinitis (108480).
• Stroke. Although there has been interest in using oral pomegranate for stroke recovery, there is insufficient reliable information about the clinical effects of pomegranate for this purpose.
• Sunburn. It is unclear if oral pomegranate extract is beneficial for sunburn prevention. Details: A small clinical study shows that taking pomegranate extract standardized to contain ellagic acid 100-200 mg daily for 4 weeks does not reduce skin pigmentation caused by UV light exposure when compared with placebo (69172). However, this study was not adequately powered to detect a difference between treatments.
• Trichomoniasis. It is unclear if oral pomegranate extract is beneficial for trichomoniasis. Details: A very small clinical study in patients with vaginal Trichomoniasis suggests that taking pomegranate extract might help to eradicate Trichomonas vaginalis infection (69286). The validity of this finding is limited by the small study size, unclear reporting, and lack of a control group. More evidence is needed to rate pomegranate for these uses.

(Read more about POMEGRANATE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Topical red raspberry leaf has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in females aged 30-65 years shows that applying a specific liquid (Antioxidant and Collagen Booster Serum, Max Biocare Pty Ltd.) containing red raspberry leaf cell culture extract 0.0005%, vitamin C 20%, and vitamin E 1% to the face nightly for 8 weeks, in addition to regular facial skin products, improves skin color, elasticity, radiance, smoothness, and appearance of wrinkles when compared with regular facial skin products alone (102355).
• Cardiovascular disease (CVD). Although there has been interest in using oral red raspberry leaf for CVD, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Congestive heart failure (CHF). Although there has been interest in using oral red raspberry leaf for CHF, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Diabetes. Although there has been interest in using oral red raspberry leaf for diabetes, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Dysmenorrhea. Although there has been interest in using oral red raspberry leaf for dysmenorrhea, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Hypertension. Although there has been interest in using oral red raspberry leaf for hypertension, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Influenza. Although there has been interest in using oral red raspberry leaf for influenza, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Labor pain. Some research suggests that oral red raspberry leaf does not reduce analgesic use during labor. Details: Clinical research shows that taking red raspberry leaf 2.4 grams daily, beginning at 32 weeks' gestation and continuing until delivery, does not decrease the need for analgesics in the perinatal time period when compared with placebo (9796). A systematic review of retrospective studies also supports these findings, showing no improvement in perineal outcomes in patients consuming red raspberry leaf prior to labor (108005).
• Menorrhagia. Although there has been interest in using oral red raspberry leaf for menorrhagia, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Obesity. It is unclear if oral red raspberry fruit is beneficial in patients with obesity. Details: Preliminary clinical research in overweight and obese adults shows that consuming frozen red raspberry fruit 280 grams daily for 8 weeks does not reduce body mass index or waist circumference when compared with control (105873).
• Osteoarthritis. It is unclear if oral red raspberry leaf extract is beneficial for knee osteoarthritis. Details: A moderate-sized clinical study in patients with knee osteoarthritis shows that taking red raspberry leaf extract 200 or 400 mg once daily for 12 weeks reduces pain at the higher dose when measured by the visual analog scale, but does not improve physical performance, physical activity, walking distance, or Western Ontario McMaster osteoarthritis index (WOMAC) global score or pain, stiffness, and function subscores when compared with placebo (112127).
• Parturition. Some research suggests that oral red raspberry leaf does not shorten the duration of labor. Details: Clinical research shows that taking red raspberry leaf 2.4 grams daily, beginning at 32 weeks' gestation and continuing until delivery, does not reduce the length of labor when compared with placebo (108005). Traditionally, doses of up to 4 grams daily have been recommended for this purpose; however, doses greater than 2.4 grams daily have not been evaluated for safety or efficacy. Further high-quality research is needed to determine the optimal dose, duration, and formulation, if any, of red raspberry leaf for this purpose.
• Pharyngitis. Although there has been interest in using topical red raspberry leaf for pharyngitis, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Pregnancy-induced nausea and vomiting. Although there has been interest in using oral red raspberry leaf for pregnancy-induced nausea and vomiting, there is insufficient reliable information about the clinical effects of red raspberry for this purpose.
• Respiratory tract infections. Although there has been interest in using oral red raspberry leaf for respiratory tract infections, there is insufficient reliable information about the clinical effects of red raspberry for this purpose. More evidence is needed to rate red raspberry leaf for this use.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Acai pulp, in a dose of up to 162.5 grams daily, has been used with apparent safety for up to 3 months in clinical research (17731,99400). There is insufficient reliable information available about the safety of acai when used topically.

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

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LIKELY SAFE ...when used orally and appropriately. Blueberry, as the whole fruit, juice, or in a powder formulation, is safe when consumed in amounts commonly found in foods (13533,92387,92388,92394,96467,97181,99139). There is insufficient reliable information available about the safety of blueberry when used topically or when the leaves are used orally.

CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods (13533,96465).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (13533,107281). There is insufficient reliable information available about the safety of blueberry for medicinal use; avoid using.

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LIKELY SAFE ...when pomegranate fruit or fruit juice is used orally and appropriately. Pomegranate juice has been safely used in studies lasting up to 3 years (4912,8310,13022,13023,13690,14137,14388,17329,91693).

POSSIBLY SAFE ...when pomegranate extract is taken orally and appropriately. A specific pomegranate ellagitannin-enriched polyphenol extract (POMx, POM Wonderful) 1-3 grams daily has been safely used for up to 18 months (17729,69261,91686,91695,91697,99100,105269). ...when pomegranate seed oil is used orally and appropriately. Pomegranate seed oil 60 mg daily has been used with apparent safety for up to 12 weeks (91685). ...when a hot water extract of pomegranate seed powder is used orally and appropriately. Pomegranate seed powder 5 grams daily has been used with apparent safety for up to 8 weeks (105270). ...when pomegranate extract is used topically on oral mucosa (13689).

POSSIBLY UNSAFE ...when the pomegranate root, stem, and peel are used orally in large amounts. Bark of the pomegranate root and stem contains the piperidine alkaloids pelletierine, pseudopelletierine, isopelletierine, and methyl isopelletierine. These alkaloids have muscle relaxant properties that have been associated with paralysis and death in animals (13687,13694,13695). Dried pomegranate peel may contain aflatoxin, which is a potent hepatocarcinogen and toxin (92018).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when the fruit or fruit juice is consumed orally and appropriately (13686,105267). There is insufficient reliable information available regarding the safety of using other forms of pomegranate or other parts of the plant during pregnancy or lactation; avoid using.

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LIKELY SAFE ...when the fruit is used orally in amounts commonly found in foods (13622).

POSSIBLY SAFE ...when the fruit is used orally and appropriately in medicinal amounts (6481,9796). There is insufficient reliable information available about the safety of red raspberry leaf when used orally or topically.

PREGNANCY: LIKELY SAFE
when the fruit is used orally in amounts commonly found in foods (13622).

PREGNANCY: POSSIBLY SAFE
when red raspberry leaf is used orally and appropriately in medicinal amounts during late pregnancy under the supervision of a healthcare provider. Red raspberry leaf is used by nurse midwives to facilitate delivery. There is some evidence that red raspberry leaf in doses of up to 2.4 grams daily, beginning at 32 weeks' gestation and continued until delivery, can be safely used for this purpose (6481,9796). Make sure patients do not use red raspberry leaf without the guidance of a healthcare professional.

PREGNANCY: LIKELY UNSAFE
when red raspberry leaf is used orally in medicinal amounts throughout pregnancy or for self-treatment. Red raspberry leaf might have estrogenic effects (6180). These effects can adversely affect pregnancy. Tell pregnant patients not to use red raspberry leaf at any time during pregnancy without the close supervision of a healthcare provider.

LACTATION: LIKELY SAFE
when the fruit is used orally in amounts commonly found in foods (13622). There is insufficient reliable information available about the safety of red raspberry leaf; avoid using.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking acai with antidiabetes drugs might interfere with glycemic control.  Details Preliminary clinical research in healthy adults has shown that taking acai may increase or decrease levels of fasting blood glucose (17731,105321).

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ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, blueberries or blueberry leaf extracts might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal and in vitro research suggests that blueberry and/or blueberry leaf extracts can lower blood glucose levels (909,36743,36759).

BUSPIRONE (BuSpar) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, blueberry juice might increase blood levels of buspirone.  Details In vitro research shows that blueberry juice can inhibit the metabolism of buspirone, possibly by inhibiting cytochrome P450 3A (CYP3A) enzymes. However, pharmacokinetic research in humans shows that drinking 300 mL of blueberry juice 30 minutes before taking buspirone hydrochloride 10 mg does not significantly affect the concentration or clearance of buspirone (92385).

FLURBIPROFEN (Ansaid, others) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, blueberry juice might increase blood levels of flurbiprofen.  Details In vitro research shows that blueberry juice can inhibit the metabolism of flurbiprofen, possibly by inhibiting cytochrome P450 2C9 (CYP2C9) enzymes. However, pharmacokinetic research in humans shows that drinking 300 mL of blueberry juice 30 minutes before taking flurbiprofen 100 mg does not significantly affect the concentration or clearance of flurbiprofen (92385).

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ACE INHIBITORS (ACEIs) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking pomegranate with ACEIs might increase the risk of adverse effects.  Details Pomegranate juice is thought to have ACE inhibitor-like effects (8310).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking pomegranate with antihypertensive drugs might increase the risk of hypotension.  Details Consuming pomegranate juice can modestly lower blood pressure (8310,13023,69373,69374).

CARBAMAZEPINE (Tegretol) Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking pomegranate with carbamazepine might increase the risk of adverse effects, although research suggests this interaction is unlikely to be clinically significant.  Details Animal research shows that pomegranate juice may inhibit cytochrome P450 3A4 (CYP3A4) metabolism of carbamazepine and increase levels of carbamazepine by 1.5 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP3A4, but might not inhibit hepatic CYP3A4 (13188). However, some human research suggests that pomegranate does not significantly inhibit CYP3A4 drug metabolism in humans (16711,16712,17326).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, pomegranate might increase levels of drugs metabolized by CYP2C9.  Details Some animal and in vitro research shows that pomegranate juice inhibits intestinal, but not hepatic, CYP2C9 isoenzyme activity (17327). However, clinical research shows that neither pomegranate juice nor pomegranate extract have a significant effect on CYP2C9 activity in humans (91694).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, pomegranate might increase levels of drugs metabolized by CYP2D6.  Details In vitro, pomegranate juice inhibits CYP2D6 (13703). However, the clinical significance of this potential interaction in humans is not known.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, pomegranate might increase levels of drugs metabolized by CYP3A4, but most research suggests this interaction is unlikely to be clinically significant.  Details Pomegranate contains several polyphenols that have individually been shown to inhibit CYP3A4. However, there is contradictory evidence about the effect of whole pomegranate juice on CYP3A4 activity. In vitro, pomegranate juice significantly inhibits the CYP3A4 enzyme, with comparable inhibition to grapefruit juice (13188,16711,17326). In an animal model, pomegranate juice inhibits CYP3A4 metabolism of carbamazepine and increases levels of carbamazepine by 1.5 times (13188); however, in human volunteers, drinking a single glass of pomegranate juice 240 mL or taking 200 mL daily for 2 weeks does not significantly affect levels of the CYP3A4 substrate midazolam after oral or intravenous administration (16711,17730). Another study in healthy volunteers shows that consuming pomegranate juice 300 mL three times daily for three days also does not significantly affect levels of simvastatin, a CYP3A4 substrate (16712,91696) This suggests that pomegranate is unlikely to significantly affect levels of CYP3A4 substrates in humans (17326).

ROSUVASTATIN (Crestor) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking pomegranate with rosuvastatin might increase the risk of adverse effects.  Details In one case, a patient taking rosuvastatin 5 mg every other day in combination with ezetimibe 10 mg daily developed rhabdomyolysis after drinking pomegranate juice 200 mL twice weekly for 3 weeks. This patient had a history of elevated creatine kinase levels while not receiving any statin treatment. This suggests a possible underlying myopathy and predisposition to rhabdomyolysis (14465).

TOLBUTAMIDE (Orinase) Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, pomegranate might increase levels of tolbutamide, although research suggests this interaction is unlikely to be clinically significant.  Details Animal research shows that pomegranate juice inhibits the cytochrome P450 2C9 (CYP2C9) metabolism of tolbutamide. Pomegranate juice increased tolbutamide levels by 1.2 times without prolonging the elimination half-life. This suggests that pomegranate juice inhibits intestinal CYP2C9, but might not inhibit hepatic CYP2C9 (17327). Despite this evidence, clinical research shows that neither pomegranate juice nor pomegranate extract have a significant effect on CYP2C9 activity in humans (91694). This interaction does not appear to be clinically significant in humans.

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, pomegranate might increase warfarin levels and increase the risk of bleeding. Also, discontinuing regular consumption of pomegranate juice might decrease warfarin levels.  Details In one case report, a patient had a stable, therapeutic bleeding time, as measured by international normalized ratio (INR), while taking warfarin in combination with pomegranate juice 2-3 times per week. The patient became subtherapeutic within about 10 days after discontinuing pomegranate juice, which required a warfarin dose increase (17328). In another case report, a patient with a stable INR for over one year presented with an INR of 14. The patient noted no changes to medications or diet but did report consuming around 3 liters of pomegranate juice over the previous week. The patient's INR stabilized upon moderation of pomegranate juice consumption (24273). The mechanism of this potential interaction is unclear.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking red raspberry leaf with anticoagulant/antiplatelet drugs might increase the risk of bleeding.  Details In vitro research suggests that red raspberry leaf extract has antiplatelet activity and enhances the in vitro effects of the antiplatelet medication cangrelor (96300). This interaction has not been reported in humans.

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Red raspberry leaf might reduce glucose levels in patients being treated with insulin.  Details In one case report, a 38-year-old patient with gestational diabetes, whose blood glucose was being controlled with medical nutrition therapy and insulin, developed hypoglycemia after consuming two servings of raspberry leaf tea daily for 3 days beginning at 32 weeks' gestation. The patient required an insulin dose reduction. The hypoglycemia was considered to be probably related to use of red raspberry leaf tea (96299).

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General ...Orally, acai seems to be well tolerated.

Other ...Raw acai fruit and juice can be contaminated with a parasitic protozoan called Trypanosoma cruzi, which causes American trypanosomiasis or Chagas Disease. A Brazilian outbreak of this disease in 2006 was linked to consumption of acai juice (17194,30245).

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General ...Orally, blueberry is generally well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, nausea, and vomiting with freeze-dried blueberries.

Gastrointestinal ...Orally, freeze-dried blueberries may cause constipation, diarrhea, nausea, and vomiting. In one clinical trial, 26% of patients taking freeze-dried blueberries 50 grams daily dropped out in the first week of the study due to gastrointestinal complaints (107278).

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General ...Orally, pomegranate fruit juice is generally well tolerated. Pomegranate fruit extract and seed oil seem to be well tolerated. Pomegranate root, stem, and peel should not be used orally in large amounts. Topically, pomegranate fruit extract seems to be well tolerated.
Most Common Adverse Effects:
Oral: Diarrhea, flatulence.

Cardiovascular ...In one clinical trial, 2% of patients experienced hyperlipidemia and hypertension after consumption of pomegranate juice (69175). However, most clinical research shows that pomegranate does not increase cholesterol or blood pressure and may actually improve these parameters in some patients (8310,13022,13023,69168,69373,69374).

Dermatologic ...Topically, pomegranate may cause urticaria (hives) in some patients (8445).

Gastrointestinal ...Orally, pomegranate may cause mild gastrointestinal adverse effects. In one clinical study, drinking pomegranate juice 8 ounces daily caused diarrhea and flatulence in 2% of patients (69175). In another clinical study, taking pomegranate extract (POMx, POM Wonderful LLC) 3000 mg daily caused diarrhea in 10% of patients. This dose of pomegranate extract also caused nausea, abdominal pain, constipation, gastrointestinal upset, and vomiting in a small number of patients (91695).

Immunologic ...Orally, pomegranate fruit or seeds may cause allergic reactions. These allergic reactions occur more commonly in people who are allergic to other plants (7674). In rare cases, pomegranate fruit can cause angioedema. Angioedema seems to occur without warning and in people who have eaten pomegranate for many years. Patients should be told to stop eating pomegranate if swelling of the tongue or face develops (7673). In one report, a patient experienced pomegranate-dependent, exercise-induced anaphylaxis. The patient developed widespread urticaria (hives) and lip edema after eating pomegranate seeds and then exercising (17331). In another report, an atopic patient experienced an allergic reaction to pomegranate fruit. Symptoms included urticaria (hives), facial angioedema, and hypotension (91692).
Topically, pomegranate may cause contact hypersensitivity characterized by urticaria (hives), angioedema, rhinorrhea, red itchy eyes, and dyspnea arising within a few minutes of exposure (8445).

Pulmonary/Respiratory ...Orally, pomegranate juice may cause nasal congestion, but this event is rare. In one clinical study, pomegranate juice was associated with nasal congestion in 2% of patients (69175). There is also one case report of a 7-year-old asthmatic child who developed bronchospasm moments after ingesting several pomegranate seeds (69149).

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General ...Orally, red raspberry fruit is well tolerated. There is currently a limited amount of information on the adverse effects of red raspberry leaf.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, and epigastric pain. However, these adverse effects do not commonly occur with typical doses.

Dermatologic ...A liquid containing red raspberry leaf cell culture extract 0. 0005%, vitamin C 20%, and vitamin E 1% (Antioxidant and Collagen Booster Serum, Max Biocare Pty Ltd.) has been reported to cause mild tingling and skin tightness (102355). It is unclear if these effects are due to red raspberry leaf, the other ingredients, or the combination.

Gastrointestinal ...Orally, red raspberry may cause gastrointestinal upset, diarrhea, and epigastric pain (112127).

Pulmonary/Respiratory ...A case of occupational asthma due to the inhalation of red raspberry powder has been reported for a 35-year-old female. Symptoms included wheezing and shortness of breath (70370).

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