Lycopene 10 mg by Wonder Laboratories

POSSIBLY EFFECTIVE

• Prostate cancer. Early findings suggests that oral lycopene might have a small benefit in preventing the development or recurrence of prostate cancer. Details: While some observational studies have found a reduced risk for prostate cancer from increased dietary lycopene intake (2405,2406,7772,7773,7895,12878,60304,60448,109432), others have found no significant association (34635,60334,60449,60457,60547). The most recent meta-analysis of these and other observational studies has found an overall modest benefit, suggesting that the risk of developing prostate cancer decreases by 1% for each additional 2 mg of daily dietary lycopene intake, and decreases by 3.5% for each 10 mcg/dL increase in plasma lycopene levels (98824). A subgroup analysis of some population research also suggests that the benefits from increased dietary lycopene may be limited to non-Hispanic White subjects (109432). Furthermore, a small clinical study in patients at high risk for developing prostate cancer with high-grade prostate intraepithelial neoplasia shows that taking lycopene (Lyc-O-Mato, LycoRed Natural Product Industries) 4 mg twice daily for one year might delay progression to prostate cancer when compared with no supplementation (14126). Numerous small heterogeneous studies have examined the effect of lycopene on serum prostate specific antigen (PSA) levels. One meta-analysis of 6 controlled clinical trials in patients with non-metastatic prostate cancer or prostatic intraepithelial neoplasia shows that taking lycopene 15-45 mg daily for 4 months does not reduce PSA levels when compared with control. However, in patients with a higher baseline PSA of over 6.5 mg/L, lycopene supplementation seems to reduce PSA levels when compared with control (105573). Other small, uncontrolled studies in patients in remission or with recurrent or metastatic prostate cancer suggest that taking lycopene (LycoRed, Jagsonpal Pharmaceuticals; Lyc-O-Mato, LycoRed Natural Product Industries Ltd.) 10-30 mg daily, or tomato products providing a mean of 43 mg lycopene daily, for 3-6 months reduces PSA levels when compared to baseline (60353,60397,60403,60417). Lycopene might also be beneficial in patients receiving surgical interventions. Small clinical studies in patients receiving orchiectomy for metastatic prostate cancer or radical prostatectomy show that taking lycopene 4 mg daily for 6 months or 30 mg daily for 3 weeks seems to reduce and normalize PSA levels when compared with baseline or control (7771,60328,60342). However, not all research has been positive. Two small clinical studies in patients with relapsed or androgen-independent prostate cancer show that taking lycopene 15-120 mg daily for up to one year does not affect PSA levels when compared with baseline (60372,60384). Many of these findings are limited due to a lack of a placebo control.

POSSIBLY INEFFECTIVE

• Bladder cancer. Dietary lycopene does not seem to affect the risk of bladder cancer. Details: Epidemiological research and population studies have not established a link between dietary intake of lycopene or lycopene serum levels and the risk of bladder cancer (2407,60411,60496,60533).
• Diabetes. Increased dietary lycopene intake does not seem to reduce the risk of diabetes or diabetic complications. Details: Population research has found that increasing intake of dietary lycopene does not decrease the risk of developing type 2 diabetes (14004,14361). Other epidemiological research in patients with type 2 diabetes has found that an increased serum concentration of lycopene is not associated with reduced cardiovascular mortality over 14 years (109768).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related macular degeneration (AMD). It is unclear if oral lycopene is beneficial in patients with AMD; the available evidence is conflicting. Details: Some observational research has found that lycopene serum levels in the lowest quintile are associated with an almost two-fold increased risk for AMD when compared with levels in the highest quintile (6110). However, other population research has found no association between lycopene serum levels or dietary lycopene intake and the risk of developing AMD (5922,10902,14007,60585).
• Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease). It is unclear if dietary lycopene helps to prevent ALS. Details: Population research has found that the highest quintile of total dietary carotenoid intake is associated with a 25% lower risk of ALS when compared with the lowest quintile. However, no association was found for lycopene intake alone (90412).
• Asthma. It is unclear if oral lycopene reduces asthma exacerbations or prevents asthma. Details: Some preliminary clinical research in adults with stable asthma shows that taking a specific tomato extract product (Lyc-O-Mato, LycoRed Natural Products Industries, Ltd.) providing lycopene 15 mg three times daily orally for up to 14 weeks does not reduce asthma exacerbations when compared with placebo (60482). However, other observational research has found that a higher dietary intake of lycopene is associated with at least a 20% lower odds of having asthma when compared with a lower dietary intake (109765). The effects of lycopene supplements are unclear.
• Atherosclerosis. It is unclear if oral lycopene is beneficial in patients with atherosclerosis. Details: Some observational research has found that higher serum lycopene levels are associated with a lesser degree of aortic or carotid atherosclerosis (1446,60329,60463). Some observational research has also found that higher serum lycopene levels are associated with a lower risk of coronary heart disease and myocardial infarction in people with atherosclerosis (7897,60538). However, there does not seem to be a link between serum lycopene levels and the risk of ischemic stroke (1449).
• Benign prostatic hyperplasia (BPH). Small studies suggest that lycopene products might improve BPH symptoms. Details: While epidemiological evidence has not found an association between dietary lycopene and the development of BPH (60365), clinical research suggests that lycopene might improve BPH-related symptoms. One small clinical study in patients with BPH shows that taking lycopene (LycoVit powder, BASF) 15 mg daily for 6 months slows the progression of BPH and improves symptom scores when compared to baseline (60399). This finding is limited by the lack a statistical comparison to the control group. Research also suggests that combination products containing lycopene might improve BPH symptoms. These products have combined lycopene 2.1 mg with pumpkin seed oil 160 mg, small-flowered willow herb 500 mg, pygeum 15 grams, and saw palmetto 660 mg (ProstateEZE Max, Caruso's Natural Health) once daily for 3 months (92164); and lycopene 5 mg with saw palmetto 320 mg and selenium 50 mcg (Profluss, KonPharma) daily for 1 year (90354).
• Brain tumor. It is unclear if oral lycopene is beneficial for various types of brain tumor. Details: A small clinical study in patients with glioblastoma multiforme or anaplastic astrocytoma shows that taking lycopene 8 mg orally daily for 3 months does not improve the response to radiotherapy and paclitaxel when compared with placebo (60441).
• Breast cancer. It is unclear if oral lycopene reduces the risk of breast cancer. Details: Some observational research has found that higher levels of lycopene in the blood and breast adipose tissue are associated with reduced breast cancer risk (10132,34634,60549,60555). However, other epidemiological research has found that neither dietary lycopene intake nor lycopene serum levels are associated with breast cancer risk (10823,15751,60344,60468,60541). Also, some population research has found that there is a possible relationship between low serum lycopene levels and an increased risk of breast cancer in Black females, but not White females (60325).
• Cardiovascular disease (CVD). It is unclear if oral lycopene reduces the risk of CVD. Details: Most epidemiological research has found that higher serum levels of lycopene and increased dietary lycopene intake are associated with modestly reduced risk of adverse cardiovascular events, including reduced incidence of coronary heart disease, myocardial infarction, stroke, and mortality (7897,9594,10418,15749,60538,102178,109434). However, evidence from clinical trials shows that lycopene may not improve most risk factors for CVD. Meta-analyses of clinical research in healthy adults or patients with at least one cardiovascular risk factor show that taking lycopene 1.44 to 75 mg daily does not improve blood pressure, lipid levels, or endothelial function when compared with control (95777,105575). These findings are limited by the heterogeneity of the included trials.
• Cataracts. It is unclear if oral lycopene is beneficial for reducing the risk of cataracts. Details: One epidemiological study has found that serum lycopene levels are inversely associated with the risk of developing cataracts (60203). However, other population studies have found no association between lycopene serum levels or dietary intake of lycopene and the development of cataracts (3219,3220,60299).
• Cervical cancer. It is unclear if oral lycopene reduces the risk of cervical cancer. Details: Epidemiological research has found that higher serum lycopene levels or higher dietary lycopene intake is associated with a reduced risk of cervical intraepithelial neoplasia and invasive cervical cancer (60429,60430,60439,60566). However, other studies have not shown this association (60388,60517,60521).
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with prostatitis and chronic pelvic pain syndrome shows that taking a specific combination of lycopene 5 mg with selenium 50 mcg and saw palmetto 320 mg (Profluss, KonPharma) daily for 8 weeks reduces pain scores by 52%, compared with a 26% reduction with saw palmetto alone (60442). It is unclear if this effect is due to lycopene, the other ingredients, or the combination.
• Cognitive function. It is unclear if oral lycopene is beneficial for improving cognitive function and memory. Details: Observational research in healthy adults has found that consuming more lycopene in the diet over 22 years is associated with lower odds of poor cognitive function (104468).
• Colorectal cancer. It is unclear if lycopene reduces the risk for colorectal cancer; the available research is conflicting. Details: Some population research has found that the highest tertile of dietary lycopene intake is associated with a 50% reduced risk for colorectal cancer when compared with the lowest tertile (2407,38845). However, other epidemiological research has found no association between dietary lycopene intake and the risk of colorectal cancer, regardless of smoking status, drinking status, geographical location, gender, and tumor location (3962,34542,95778).
• Esophageal cancer. It is unclear if oral lycopene is beneficial for preventing esophageal cancer. Details: A meta-analysis of population research has found that high dietary intake of lycopene is associated with a 25% reduced odds of developing esophageal squamous cell carcinoma when compared with low dietary intake of lycopene (91159).
• Exercise-induced asthma. It is unclear if oral lycopene is beneficial for preventing exacerbations of exercise-induced asthma. Details: One very small clinical trial in children and adults with exercise-induced asthma shows that taking a specific tomato extract product (Lyc-O-Mato, LycoRed Natural Products Industries, Ltd.) providing lycopene 30 mg daily for 1 week seems to reduce the incidence of exercise-induced asthma exacerbations, but does not improve certain measures of lung function, when compared to baseline (7898). However, another very small study in adolescent athletes with exercise-induced asthma shows that taking the same product and dose for 1 week does not improve post-exercise lung function or reduce exacerbations when compared with placebo (60358). This study may have been underpowered to detect a difference between groups.
• Exercise-induced muscle damage. Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adult long-distance runners shows that taking a combination product (Lycored Ltd.) containing lycopene 5 mg, other carotenoids 4 mg, folic acid 0.1 mg, tocopherols 4 mg, and rosemary extract orally once daily for 4 weeks reduces muscle damage associated with a 2-hour run when compared with placebo (98825).
• Gastric cancer. It is unclear if oral lycopene reduces the risk of gastric cancer. Details: Preliminary observational research in adult males has found that high dietary intake of lycopene is associated with 0.87 lower odds of having stomach cancer when compared with low dietary intake (109436).
• Gingivitis. Small studies suggest that ingesting or injecting oral lycopene products might improve gingivitis. Details: Preliminary clinical research shows that taking a specific oral lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 8 mg daily for 2 weeks, or receiving a single injection of lycopene gel 2 mg into the gums, reduces gingivitis when compared with placebo (60400,60473). However, using a combination product (Lycotas, Intas Pharmaceuticals) containing lycopene 2 mg, vitamin C 50 mg, vitamin A 2500 units, zinc sulfate 20.6 mg, and chromium picolinate 75 mcg orally twice daily for 2 weeks does not improve moderate gingivitis or mild to moderate periodontitis when compared with placebo in people who have also undergone scaling and root planning (92172).
• Helicobacter pylori. It is unclear if oral lycopene helps to eradicate H. pylori. Details: A small clinical study in patients diagnosed with H. pylori shows that adding lycopene 30 mg daily for 1 month to standard therapy with metronidazole, amoxicillin, omeprazole, and bismuth does not increase the rate of H. pylori elimination when compared with standard therapy alone (60480).
• Human papillomavirus (HPV). It is unclear if oral lycopene is beneficial in patients with HPV. Details: Epidemiological research in females has found that higher plasma levels of lycopene are associated with a faster rate of oncogenic HPV clearance, with an average of 8.5 months, when compared with lower levels of plasma lycopene, with an average of 11-12 months (12177).
• Hyperlipidemia. Most research shows that oral lycopene doesn't reduce low-density lipoprotein (LDL) cholesterol levels; however, effects on other lipid levels are unclear. Details: A subgroup meta-analysis of 3 small clinical studies in adults with hyperlipidemia shows that taking lycopene 7-15 mg daily or tomato juice containing lycopene 2.5 mg 4 times weekly for 8 weeks does not improve LDL cholesterol levels when compared with control (105575). Another subgroup meta-analysis of 9 studies in adults without hyperlipidemia shows that consuming lycopene, in supplements or in tomato products, also does not seem to reduce LDL cholesterol levels when compared with both active and inactive controls (105575). This finding is limited by the heterogeneity of interventions and patient populations. In contrast, one small clinical study in Japanese patients with borderline high cholesterol shows that taking 50 grams of a semi-dried tomato containing lycopene 22-27.8 mg daily for 12 weeks modestly reduces LDL cholesterol levels, but does not affect high-density lipoprotein (HDL) cholesterol levels, when compared with taking 50 grams of tomato without lycopene (102180). Subgroup meta-analyses also show that taking lycopene does not reduce triglyceride levels or improve HDL cholesterol levels (105575). However, a meta-analysis of 14 small clinical trials including healthy subjects and subjects with metabolic disorders shows that taking lycopene 6-75 mg orally daily for 1 week to 6 months moderately improves both HDL cholesterol and triglyceride levels when compared with control. A subgroup analysis suggests lycopene may improve lipid levels in unhealthy, but not healthy, subjects. However, the validity of this study is limited by high heterogeneity and the exclusion of LDL cholesterol levels from the analysis (109431). Also, a clinical study in patents with ischemic heart failure shows that taking lycopene 25 mg daily for 8 weeks modestly reduces levels of triglycerides (109773). In postmenopausal females, taking a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 4 mg orally twice daily for 6 months also modestly increases triglyceride levels (109694). However, there was no effect on other lipid levels in either of these studies (109694,109773).
• Hypertension. Small clinical studies suggest that some lycopene products might reduce blood pressure in patients with hypertension. However, lycopene does not seem to reduce the risk for hypertension. Details: Observational research has found no link between serum lycopene levels and the risk for hypertension (60419). Additionally, lycopene supplements do not seem to reduce blood pressure in patients without hypertension or with pre-hypertension (42079,105572,105575). However, some clinical research suggests that lycopene may be beneficial for lowering blood pressure in people with hypertension. A network meta-analysis of 4 small clinical trials in patients with hypertension shows that taking standardized tomato extract containing lycopene 10-30 mg daily for 4-12 weeks reduces systolic and diastolic blood pressure by about 8 mmHg and 4 mmHg, respectively, when compared with placebo. This benefit was not seen with supplements containing only lycopene or tomato products without standardized lycopene content (105572). Specific tomato extract products (Lyc-O-Mato or Tomato Nutrient Complex, LycoRed, Ltd.), were used in some studies (60415,102182).
• Lung cancer. It is unclear if oral lycopene is beneficial in patients with lung cancer. Details: Some epidemiological research has found that higher dietary lycopene intake or serum levels are linked to a decreased risk of lung cancer (2595,60332,60363,60550). However, other epidemiological research has found no association between dietary intake or blood levels of lycopene and lung cancer risk (60316,60520,60522,60554).
• Male infertility. It is unclear if oral lycopene is beneficial in male patients with infertility. Details: A small clinical study in males with idiopathic infertility shows that taking lycopene 2 mg orally twice daily for 3 months improves sperm concentration, motility, and morphology when compared with baseline (60340). The validity of this finding is limited by the lack of a control group.
• Melasma. Topical lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with melasma shows that applying a sunscreen cream containing lycopene 0.05% and wheat bran extract 3.45% twice daily for 12 weeks seems to modestly reduce the severity of melasma, but not the area of affected skin, when compared with a placebo cream (105569).
• Menopausal symptoms. Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with menopausal symptoms shows that taking a specific oral combination of lycopene with calcium, vitamin D3, astaxanthin, and citrus bioflavonoids (Cor.Con. International) daily for 8 weeks reduces hot flashes, incontinence, joint pain, anxiety, and depression when compared with no treatment (19198). It is not clear if this effect is due to lycopene, other ingredients, or the combination.
• Obesity. It is unclear if a diet high in lycopene helps to reduce weight. Details: A small clinical study in obese adults shows that ingesting a drink with a carrot paste containing lycopene 7.6-8.6 mg, along with either high-lutein kale paste or low-lutein cabbage paste, daily for 8 weeks does not reduce body weight or waist circumference, but seems to modestly reduce the amount of visceral fat, when compared with baseline (105574). This finding is limited due to a lack of comparison to the control group, which consumed a carrot paste containing no lycopene.
• Oral leukoplakia. It is unclear if oral lycopene is beneficial in patients with oral leukoplakia. Details: A small clinical study in patients with oral leukoplakia shows that taking a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 2-4 mg orally twice daily for 3 months improves clinical and histological symptoms in a dose-dependent manner when compared with placebo (15748). Preliminary clinical research also shows that taking lycopene 6 mg, along with vitamin E 400 IU and selenium 200 mcg twice daily, for 3 months has a large beneficial effect on lesion size when compared with placebo (109772).
• Oral submucous fibrosis. Small studies suggest that oral lycopene might slightly improve mouth opening in patients with oral submucous fibrosis. It is unclear if lycopene reduces pain or burning sensation. Details: A meta-analysis of 5 small clinical studies in patients with oral submucous fibrosis, usually from chewing betel nuts and/or tobacco, shows that taking lycopene 4-8 mg twice daily for 1-3 months seems to improve maximal mouth opening, but not pain, when compared with control (105570). Clinical studies reported an average mouth opening increase of 3.5-4 mm when compared to baseline (60381,98823,102181). It is unclear if this improvement is clinically significant. Furthermore, although two clinical studies using specific tomato extracts (LycoRed, Jagsonpal Pharmaceuticals; MintovitL by Obsurge Biotech Limited) show that lycopene also reduces the burning sensation in the mouth (98823,102181), the meta-analysis did not confirm this benefit (105570). All of the available studies have been conducted in India and Saudi Arabia; it is unclear if these results are generalizable to other locations.
• Osteoporosis. It is unclear if oral lycopene reduces the risk of osteoporosis. Details: Population research in adults at least 50 years of age has found that high dietary intake of lycopene is not associated with bone mineral density or osteoporosis risk when compared with low dietary intake (107289).
• Ovarian cancer. It is unclear if oral lycopene reduces the risk of ovarian cancer. Details: Some epidemiological evidence has found that a diet rich in carotenoids, including lycopene, is associated with a decreased risk of premenopausal ovarian cancer (10133). However, other epidemiological research has found no association (60373,60534).
• Overall mortality. It is unclear if oral lycopene reduces the risk of overall mortality. Details: Preliminary observational research in adults undergoing cancer screening has found that moderate dietary intake of lycopene, defined as 5.61-8.43 mg daily, is associated with a lower risk of overall mortality and cardiovascular disease-related mortality when compared with low dietary intake of lycopene, defined as less than 2.79 mg daily. However, higher dietary intake of lycopene of 8.44 mg or greater was not associated with mortality risk (109434).
• Pancreatic cancer. It is unclear if oral lycopene helps to prevent pancreatic cancer. Details: Epidemiological research has found that high dietary intake of lycopene is associated with a reduced risk of pancreatic cancer. Intake in the highest quartile was associated with a 31% reduction in risk when compared with the lowest quartile (15750).
• Parkinson disease. It is unclear if oral lycopene helps to prevent Parkinson disease. Details: Epidemiological research has found that neither dietary intake nor blood levels of lycopene is associated with the risk of developing Parkinson disease (91164).
• Polymorphous light eruption (PMLE). Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with PMLE shows that taking a combination of lycopene 2.5 mg, beta-carotene 4.7 mg, and Lactobacillus johnsonii 500 million CFU (Inneov Sun Sensitivity, Laboratoires Innéov) daily for 12 weeks reduces skin lesion severity after a single exposure to light when compared with placebo (90276). It is not clear if this effect is due to lycopene, other ingredients, or the combination.
• Pre-eclampsia. It is unclear if oral lycopene is beneficial in patients with pre-eclampsia. Details: Epidemiological research has found that the highest intake of lycopene during pregnancy is associated with 45% reduced odds of having pre-eclampsia when compared with the lowest intake (109762). However, results from clinical research are mixed. One clinical study in healthy primigravidae shows that taking a specific oral lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 2 mg twice daily, starting between weeks' 16 and 20 of pregnancy and continuing until delivery, lowers mean diastolic blood pressure and reduces the incidence of pre-eclampsia, intra-uterine growth retardation, and preterm labor when compared with placebo (60337). However, another clinical study in this same population shows that taking this same lycopene supplement only once daily, starting between weeks' 12 and 20 of pregnancy, does not reduce the incidence of pre-eclampsia when compared with placebo. Furthermore, the rates of preterm labor and low birth weight were higher in those taking lycopene when compared with placebo (60428). The reasons for these conflicting findings are unclear; larger, high-quality studies are needed to clarify these findings.
• Renal cell carcinoma. It is unclear if oral lycopene reduces the risk for renal cell carcinoma. Details: Observational research has found no association between dietary lycopene intake and the risk of developing renal cell carcinoma (60379).
• Sunburn. Small studies suggest that consuming tomato paste with oral lycopene might prevent sunburn. Details: Small clinical studies in healthy volunteers shows that taking lycopene 10-16 mg daily for 12 weeks, in the form of tomato paste or a tomato extract (Lyc-O-Mato), may provide some protection against experimentally-induced sunburn when compared to baseline or control (23012,60324,60452). More evidence is needed to rate lycopene for these uses.

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POSSIBLY EFFECTIVE

• Dyslipidemia. Taking full-fat rice bran, reduced-fat rice bran, or rice bran oil daily appears to modestly reduce lipoprotein (LDL) cholesterol levels. The effects of rice bran on other types of cholesterol are unclear. Details: Clinical research in adults with hypercholesterolemia shows that taking full-fat rice bran 85 grams daily for 6 weeks lowers total cholesterol by 8% and LDL cholesterol by 14% when compared with placebo. Rice bran does not seem to affect triglycerides or high-density lipoprotein (HDL) cholesterol (865). Conversely, a meta-analysis of 8 small clinical studies in patients with hypercholesterolemia, type 2 diabetes, or who have survived colorectal cancer shows that taking rice bran 20 to 100 grams/day does not improve total cholesterol, LDL, HDL, or triglycerides when compared with control (112092). However, the interpretation of these findings is limited by the heterogeneity of patients, dosages, and study designs included in the analysis. The oil from rice bran has also been shown to affect the lipid profile (1354,97524,100481,106591). Multiple meta-analyses of small clinical studies show that taking rice bran oil for 2.5-13 weeks reduces LDL cholesterol levels by 7-8 mg/dL when compared with control. However, rice bran oil does not appear to affect HDL cholesterol levels. Rice bran oil may also modestly lower triglyceride levels; however, results are conflicting between meta-analyses (97524,106591). The validity of these findings is limited by inclusion of low-quality studies and the inclusion of patients without hypercholesterolemia at baseline. The effectiveness of rice bran oil may also depend on the content of gamma-oryzanol. A small clinical study in patients with hyperlipidemia shows that taking rice brain oil 30 mL containing 4000, 8000, and 11000 ppm gamma-oryzanol daily for 4 weeks decreases LDL-C levels when compared with control. The greatest effects occurred in the patients receiving higher gamma-oryzanol content (8000 and 11000 ppm) (100481).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Clinical and population research suggest that consuming dietary cereal fiber, including rice bran, doesn't seem to reduce the risk of colorectal cancer. Details: Clinical research in adults with colorectal adenomas shows that increasing dietary fiber, including rice bran, for up to 4 years does not reduce the risk of recurrent adenomas (4820). Observational research in females has also found that increasing dietary fiber consumption, including rice bran, for up to 16 years is not associated with colorectal cancer risk (4821). However, the validity of these studies is limited by the use of multiple sources of dietary fiber.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alcohol use disorder. Although there has been interest in using oral rice bran for alcohol use disorder, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Alopecia areata. Although there has been interest in using topical rice bran for alopecia areata, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Androgenic alopecia. It is unclear if topical rice bran is beneficial in patients with androgenic alopecia. Details: One small clinical study shows that applying dermal rice bran 5% supercritical CO2 extract (RB-SCE) 4 mL to the scalp twice daily for 16 weeks improves hair density and visual ratings of hair growth in males, but not females, with androgenic alopecia when compared with placebo (97523).
• Athletic performance. Although there has been interest in using oral rice bran for athletic performance, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Atopic dermatitis (eczema). It is unclear if topical rice bran is beneficial in patients with atopic dermatitis. Details: Low-quality observational research has found that using a topical rice bran broth bath for 2-5 months reduces skin symptoms in approximately 69% to 94% of patients with atopic dermatitis when compared with baseline. However, the validity of this study is limited by the lack of a comparator group (872).
• Cardiovascular disease (CVD). There is limited evidence on the oral use of rice bran oil in coronary artery disease (CAD). Details: Preliminary clinical research in adult males who recently underwent angioplasty for CAD shows that taking oral rice bran oil 30 grams daily for 8 weeks improves left ventricular ejection fraction by 35% more when compared with taking sunflower oil 30 grams daily. Taking rice bran oil also improves triglyceride and low-density lipoprotein cholesterol levels, but not high-density lipoprotein cholesterol levels, when compared with placebo (106590).
• Diabetes. It is unclear if oral rice bran is beneficial in patients with type 2 diabetes. Details: A small clinical study in adults with type 2 diabetes shows that ingesting stabilized rice bran 20 grams once daily for 12 weeks does not reduce fasting blood glucose, postprandial glucose, or glycated hemoglobin (HbA1c) when compared with ingesting a placebo of 20 grams milled rice flour (97522). However, this study may not have been adequately powered to identify a difference between groups.
• Gastric cancer. Although there has been interest in using oral rice bran to prevent gastric cancer, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Halitosis. It is unclear if oral rice bran is beneficial in patients with halitosis. Details: Preliminary clinical research shows that swishing with 15 mL of rice bran oil for 10 minutes and spitting it out, also referred to as "oil pulling", once daily for 14 days, improves halitosis scores when compared with baseline in pregnant adults with halitosis. Rice bran oil was similarly effective to sesame oil or chlorhexidine for reducing halitosis (97526).
• HIV/AIDS. Although there has been interest in using oral rice bran for HIV/AIDS, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Hypercalciuria. It is unclear if oral rice bran is beneficial in patients with hypercalciuria. Details: Preliminary observational research in adults with idiopathic hypercalciuria shows that taking oral defatted rice bran 10 grams twice daily for up to 3 years reduces annual kidney stone recurrence by 83% when compared with baseline (876). The validity of this study is limited by the lack of a comparator group.
• Hypertension. Although there has been interest in using oral rice bran for hypertension, there is insufficient reliable information about the clinical effects of rice bran for this purpose.
• Insomnia. It is unclear if oral rice bran is beneficial in patients with insomnia. Details: A small clinical study in patients with disturbed sleep shows that taking a specific rice bran extract (S&D Co.) 1000 mg daily for 2 weeks improves total sleep time by about 20 minutes when compared with placebo. Taking rice bran extract also modestly improves sleep efficiency and sleep quality scores when compared with placebo (103760).
• Obesity. Although there has been interest in using oral rice bran for obesity, there is insufficient reliable information about the clinical effects of rice bran for this purpose. More evidence is needed to rate rice bran for these uses.

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LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods (2406,7772,7773). ...when used orally in supplemental doses. Lycopene supplements have been used safely in doses of 15-45 mg daily for 4 to 6 months (60389,60399,60482,102180,102182,109431). Some limited evidence suggests that 120 mg daily is safe for up to one year (60372).

PREGNANCY: LIKELY SAFE
when consumed in amounts commonly found in foods. There is insufficient reliable information available about the safety of lycopene supplements during pregnancy. Small, low-quality clinical studies have shown conflicting results about the safety of using lycopene 2-4 mg daily during pregnancy (60337,60428).

LACTATION: LIKELY SAFE
when consumed in amounts commonly found in foods. There is insufficient reliable information available about the safety of lycopene supplements during lactation; avoid using in amounts greater than those typically found in foods.

(Read more about LYCOPENE)

LIKELY SAFE ...when used orally and appropriately. Rice bran and rice bran oil in doses of up to 30 grams daily have been used safely in studies lasting up to 5 years. Higher doses, up to 85 grams daily, have been used safely for 6 weeks in clinical trials (865,876,877,880,1354,106588,106590). There is insufficient reliable information available about the safety of topical rice bran.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in infants. Rice bran 1-5 grams daily for up to 6 months has been consumed with apparent safety by infants 6-12 months of age (103761).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods. There is insufficient reliable information available about the safety of rice bran when used for medicinal purposes during pregnancy and lactation; avoid using.

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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 lycopene with anticoagulant or antiplatelet drugs might increase the risk of bleeding.  Details In vitro research shows that lycopene has antiplatelet effects (60360,60375,92177).

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General ...Orally, lycopene is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal complaints, skin rash.

Cardiovascular ...A case of chest pain has been reported in a pregnant patient who was taking a specific lycopene product (LycoRed, Jagsonpal Pharmaceuticals) 2 mg daily (60428). The role of lycopene in this event has not been determined.

Dermatologic ...Orally, lycopene supplements have been reported to cause allergic skin reactions in some clinical studies (60409,60417). Skin rash also occurred in a pregnant patient who was taking a specific lycopene product (LycoRed, Jagsonpal Pharmaceuticals) (60428).
There is at least one case report of carotenoderma, with a yellow-orange coloration in the stratum corneum of the skin, in a 26-year-old female who consumed 20-30 cherry tomatoes and 180 mL tomato juice, as well as other carotenoid-rich foods, daily for up to 10 years. Plasma levels of carotenoids, mainly lycopene, were elevated (109774).

Gastrointestinal ...Orally, gastrointestinal side effects associated with use of lycopene supplements include diarrhea, flatulence, abdominal distension, nausea, vomiting, dyspepsia, and anorexia (60372,60384,60417,60433,60464).

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General ...Orally, rice bran is generally well tolerated. However, increasing the amount of bran in the diet can cause transient abdominal discomfort, flatulence, and erratic bowel habits.
Most Common Adverse Effects:
Orally: Abdominal discomfort, erratic bowel habits, flatulence.
Topically: Erythema, itching.
Serious Adverse Effects (Rare):
All ROAs: Anaphylactic reactions, including urticaria and angioedema.

Dermatologic ...Topically, rice bran broth baths can cause itching and skin redness (872). In rare cases, rash and itching from rice bran has been associated with contact infestation with Pyemotes tritici, an arthropod commonly called straw itch mite (2284).

Gastrointestinal ...Orally, increasing the amount of bran in the diet can cause erratic bowel habits, flatulence, and abdominal discomfort during the first few weeks (272,106588).

Immunologic ...Orally and topically, rice bran can cause allergic reactions such as urticaria, angioedema, wheezing, itching, and cough (100733,106589). In a case report, a 5-year-old male presented with allergic eczema, urticaria, and cough due to rice bran ingestion (100733). In another case report, a 14-year-old male developed food-dependent, exercise-induced anaphylaxis after consuming 150 grams of rice bran. The 52-kDa and 63-kDa globulin constituents in rice bran have both been implicated as the source of allergic reactions (100732,106589). These constituents are not typically present in cooked, polished rice (106589).

Other ...Be aware that rice bran is a source of inorganic arsenic, which is known to negatively impact long-term health. The amount of inorganic arsenic in rice bran is unknown. However, a small analysis of powder and tablet rice bran products shows that, to exceed the provisional tolerable weekly intake of inorganic arsenic, a person weighing 65 kg would need to consume over 295 grams of rice bran tablets daily or 109 grams of rice bran powder daily. These amounts are higher than the recommended amount of rice bran tablet (3 grams daily) and rice bran powder (10-20 grams daily) listed on the labels of most available supplements (100500).

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