Oat Bran 1500 mg [Discontinued] by Nature's Harbor

LIKELY EFFECTIVE

• Coronary heart disease (CHD). A diet high in soluble fiber, such as that found in oats, reduces the risk of CHD. Details: Clinical research shows that a diet containing foods high in fiber, such as oats, oat bran, or whole oat flour, reduces the risk of CHD (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the US Food and Drug Administration (FDA) approved a health claim stating that consuming at least 3 grams of soluble fiber per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Hypercholesterolemia. A diet rich in soluble fiber, such as that found in oats, can reduce cholesterol by a moderate amount. Details: Oats, oat bran, and other soluble fibers can modestly reduce total and low-density lipoprotein (LDL) cholesterol when consumed as part of a diet low in saturated fat. Consuming 56-150 grams of whole oat products such as oatmeal and oat bran, containing 3.6-10 grams of soluble fiber daily, can significantly lower total and LDL cholesterol levels. For each gram of soluble fiber consumed, total cholesterol decreases by about 1.4 mg/dL and LDL by about 1.2 mg/dL. Eating 3-10 grams of soluble fiber daily can reduce total cholesterol by about 4-14 mg/dL (4976,4977,5786,5788,5792,5794,5795,8521,107749); however, doses greater than 10 grams daily don't seem to increase effectiveness (5788). Eating three bowls of oatmeal (28 gram servings) daily can decrease total cholesterol by about 5 mg/dL (4972,4973,4974,4975,4976,4977,5786,5788,6188). Oat bran products, such as oat bran muffins and oat bran flakes, may vary in their ability to lower cholesterol, depending on the total soluble fiber content and other dietary variables (6188). Whole oat products might be more effective for lowering LDL and total cholesterol than foods containing oat bran plus soluble fiber (10145).

POSSIBLY EFFECTIVE

• Diabetes. A diet rich in whole grains, such as oats, may help prevent diabetes or improve blood glucose control in patients with type 1, type 2, or gestational diabetes. Details: Population research shows that for every 16 gram daily serving of whole grains, including oats, there is a 7% to 11% lower risk of developing type 2 diabetes (100622). There is also evidence that consuming oats can decrease blood glucose and insulin levels, as well as lipid levels, in patients with diabetes. The glycemic effects of oats depend on the level of processing of the oat products. Consuming intact oat kernels or thick-cut oats (>0.6 mm) reduces postprandial blood glucose and insulin, but consuming thin-cut, or "quick", oats has no effect (105536). Clinical research shows that consuming oats and oat bran for 4-8 weeks decreases pre-prandial blood glucose, 24-hour plasma glucose, glycated hemoglobin (HbA1c), insulin levels, and low-density lipoprotein (LDL) cholesterol in people with type 2 diabetes (4980,4982,6266,103345). Various doses have been used, including 3 grams of soluble fiber daily, or bread providing 34 grams of total fiber daily (9 grams of soluble fiber) (4961,4980). Additional clinical research in obese adults with type 2 diabetes shows that eating whole grain oats 50-100 grams daily in place of other carbohydrates reduces postprandial blood glucose by 19-27 mg/dL when compared with other carbohydrates in a healthy diet. After 1 year, the groups consuming 50 grams and 100 grams of oats had an additional 0.48% and 0.64% reduction in HbA1c, respectively, when compared with the regular healthy diet group (97520). There is also some evidence that consuming oats 50 grams daily, containing 25 grams of soluble fiber, might be more effective for improving glycemic control and decreasing hyperinsulinemia than the standard moderate fiber diet recommended by the American Diabetes Association (ADA) (6266). Oats have also been evaluated in adolescents with type 1 diabetes. One very small clinical study shows that taking 50 grams of a specific oat product (Betaglucare), providing beta-glucans 6 grams, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with taking only 25 grams of the product daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the duration of hypoglycemia or hyperglycemia between groups (105261). Oats have also been evaluated in patients with gestational diabetes. A randomized, controlled trial shows that taking 30 grams of a specific oat bran product (OAB; Golden Light Cup Company) orally twice daily at lunch and dinner for 4 weeks improves mean fasting blood glucose and two-hour postprandial glucose when compared with a control group. After 4 weeks, the mean fasting blood glucose and 2-hour postprandial glucose in the treatment group were 85 mg/dL and 104 mg/dL, respectively, compared with 93 mg/dL and 117 mg/dL, respectively, in the control group (107751). The validity of this study is limited by the short treatment duration and lack of follow-up.
• Gastric cancer. A diet rich in soluble fiber, such as that found in oats, might reduce the risk of gastric cancer. Details: Observational research has found that consuming a diet that includes cereal fiber, such as oats and oat bran, might reduce the incidence of gastric cancer (10435).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Regular consumption of oats does not seem to reduce the risk of colorectal cancer. Details: Observational research has found that consuming oat bran or oats orally doesn't seem to reduce the risk of colon cancer. Additionally, consuming fiber, including oat-bran fiber, is not associated with a reduction in the risk for recurrence of colorectal adenomas (4820,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical oats for acne, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Anxiety. Although there is interest in using oral oats for anxiety, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Atopic dermatitis (eczema). Topical colloidal oatmeal cream may be beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that applying a cream containing colloidal oatmeal 1% daily for 2 weeks has a moderate effect on the severity of atopic dermatitis when compared with baseline (103344). The validity of this finding is limited by the lack of a comparator group. Other research suggests that colloidal oatmeal may be beneficial when used in combination with topical steroids. Clinical research shows that the benefits obtained from applying an ointment containing fluocinolone 0.025% to the hands for 2 weeks were better maintained in the patients who also used a cream containing colloidal oatmeal 1% during this time period and for an additional 4 weeks when compared with patients using fluocinolone and the cream base without colloidal oatmeal. Quality of life was also improved in the patients using colloidal oatmeal (103340).
• Breast cancer. Observational research suggests that regular oatmeal intake may be associated with reduced mortality from breast cancer. Details: Population research in postmenopausal patients has found that those who have eaten 50 grams of oatmeal daily prior to a breast cancer diagnosis have a 20% reduced risk of all-cause mortality in the 7 years following the diagnosis when compared with patients who have not eaten oatmeal. However, no benefit was seen when post-diagnostic oatmeal intakes were examined (103343).
• Burns. Although there is interest in using topical oats for burns, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral oats for CFS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Cognitive function. It is unclear if oral oats are beneficial in healthy adults with mild memory impairment. Details: Preliminary clinical research in healthy middle-aged adults with self-reported memory decline shows that consuming a specific wild green-oats extract (Neuravena, Frutarom) 800 mg as a single dose improves overall speed, but not overall accuracy, of cognitive performance when compared with placebo. However, a higher dose of 1600 mg was ineffective (97519).
• Dry skin. It is unclear if applying lotion containing colloidal oat extract improves dry skin to a greater extent than other lotion products. Details: Preliminary clinical research shows that applying a lotion containing colloidal oat extract (Aveeno Active Naturals Skin Relief 24Hr Moisturizing Lotion, Johnson & Johnson) twice daily for 2 weeks improves itchiness, cracking, scaling, dryness, and roughness when compared to baseline in females with dry skin (91458). Additional preliminary clinical research shows that applying a colloidal oatmeal lotion to the legs twice daily for three weeks reduces skin dryness and improves skin integrity when compared to baseline in adults with dry skin (97518). The validity of these findings is limited by the lack of a comparator group.
• Exercise-induced muscle soreness. It is unclear if oral oats are beneficial for exercise-induced muscle soreness. Details: A small clinical trial shows that eating two cookies containing oat flour 60 grams daily for 8 weeks reduces muscle soreness 48 or 72 hours after downhill running when compared with baseline (103341).
• Fat redistribution syndrome. It is unclear if oral oats are beneficial for fat redistribution syndrome. Details: Consumption of a high fiber diet, including oats, with adequate energy and protein might prevent fat deposition in patients with HIV. A one-gram increase in total dietary fiber may decrease the risk of fat deposition by 7% (12517).
• Gallbladder disease. Although there is interest in using oral oats for gallbladder disease, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Hypertension. It is unclear if oral oats are beneficial for hypertension. Details: Observational research has found that consumption of oats as oatmeal or oat cereal does not seem to reduce diastolic blood pressure (DBP) or systolic blood pressure (SBP) in males with minor elevations in blood pressure (2956). A randomized, controlled trial in patients with stage 1 hypertension receiving dietary guidance shows that taking 30 grams of oat bran, providing 8.9 grams of dietary fiber, once daily with breakfast or in between meals for 3 months improves various blood pressure measures when compared with dietary guidance alone. After 3 months of treatment, 24-hour maximum SBP and DBP decreased by 14 mmHg and 11 mmHg, respectively, and office SBP and DBP decreased by 15 mmHg and 10 mmHg, respectively. Oat consumption may also have impacted antihypertensive medication use. Two patients in the control group increased doses of antihypertensive medications, whereas 6 patients in the treatment group decreased doses and 1 patient discontinued use (107750). The effect of oral oat bran on patients with stage 2 hypertension or pre-hypertension is unknown.
• Irritable bowel syndrome (IBS). Although there is interest in using oral oats for IBS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Metabolic syndrome. Limited research suggests that oats may not be beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that adding oat bran 40 grams daily for 6 weeks to a low-calorie diet does not reduce the incidence of metabolic syndrome. Oat bran also does not improve body weight, blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, or blood glucose levels when compared with a low-calorie diet alone in patients with metabolic syndrome (103342).
• Osteoarthritis. Although there is interest in using oral oats for osteoarthritis, there is insufficient reliable information about the clinical effects of oats for this condition.
• Pruritus. Applying oat lotion topically may improve some types of pruritus. Details: Preliminary clinical research shows that applying an oat lotion (Espanol) twice daily for up to 2 weeks can decrease itching intensity by about 20% when compared to baseline in patients with pruritus associated with chronic kidney disease (uremic pruritus). This decrease is similar to the effects of applying vinegar 5% solution or taking hydroxyzine 10 mg orally. However, applying the oat lotion does not appear to decrease the frequency of itching (91457).
• Psoriasis. Although there is interest in using topical oats for psoriasis, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Rheumatoid arthritis (RA). Although there is interest in using oral oats for RA, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Stroke. It is unclear if oral oats are beneficial for reducing the risk of stroke. Details: Population research suggests that consuming oatmeal for breakfast once weekly might reduce the incidence of stroke by a small amount when compared with consuming white bread or eggs for breakfast (103337).
• Ulcerative colitis. Oral oats have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific oat-based product (Profermin, Nordisk Rebalance) containing fermented oat flour, Lactobacillus plantarum, barley malt flour, and lecithin, 250 mL orally twice daily for 8 weeks, reduces disease activity and increases remission in about two-fold more patients with relapsing ulcerative colitis, when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).
• Wound healing. Although there is interest in using topical oats for wound healing, there is insufficient reliable information about the clinical effects of oats for this purpose. More evidence is needed to rate oats for these uses.

(Read more about OATS)

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 food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).

POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).

(Read more about OATS)

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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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.  Details Consuming oats can decrease blood glucose in patients with diabetes (4980,4982,6266,103345). In those who require insulin, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Concomitant use of oats and insulin might increase the risk of hypoglycemia.  Details In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

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(Read more about RICE BRAN)

General ...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.

Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).

Gastrointestinal ...When consumed orally, oats provide fiber. Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).

(Read more about OATS)

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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