Gammanol Forte by Biotics Research Corporation

POSSIBLY EFFECTIVE

• Dyslipidemia. Small studies show that oral gamma-oryzanol might decrease total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels in patients with dyslipidemia. Details: Most clinical research in patients with dyslipidemia, comprised of small clinical studies, shows that gamma-oryzanol 100-300 mg daily for up to 2-6 months decreases total cholesterol, LDL cholesterol, and triglyceride levels, although effects on high-density lipoprotein (HDL) cholesterol levels are mixed (752,757,51108,51109). Other preliminary clinical evidence in patients with dyslipidemia shows that taking gamma-oryzanol 40.2 mg with vitamin E 4 mg, omega-3 fatty acids 1100 mg, and niacin 18 mg daily for 4 months reduces LDL cholesterol by an additional 23 mg/dL when compared with vitamin E and omega-3 fatty acids (51073). Gamma-oryzanol as a component of rice brain oil has also been evaluated. While rice bran oil has been shown to lower lipid levels, it is unclear if gamma-oryzanol content alters outcomes (51066,100481). One small clinical study in males with mild hypercholesterolemia shows that consuming rice bran oil containing a high amount of gamma-oryzanol (0.8 grams daily) as part of the diet for 4 weeks lowers LDL and total cholesterol to the same degree as rice bran oil low in gamma-oryzanol (0.05 grams daily) (51066). However, another small clinical study in patients with hyperlipidemia shows that taking rice brain oil 30 mL containing 8000 or 11000 ppm gamma-oryzanol daily for 4 weeks decreases LDL-C levels to a greater extent than oil containing 4000 ppm gamma-oryzanol (100481).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Although there is interest in using oral gamma-oryzanol to improve athletic performance, there is insufficient reliable information about the clinical effects of gamma-oryzanol for this purpose.
• Atopic dermatitis (eczema). It is unclear if topical gamma-oryzanol is beneficial for eczema in children. Details: A small clinical study in children shows that bathing in bathwater containing 20 mL of a solution containing gamma-oryzanol 0.5% daily for up to 6 months appears to improve symptoms of atopic dermatitis when compared with baseline (51112). The validity of this finding is limited by the lack of a comparator group.
• Hypertension. Oral gamma-oryzanol has only been evaluated in combination with sesame oil; its benefits when used alone are unclear. Details: Preliminary clinical research in patients with hypertension shows that using a 20:80 blend of sesame oil and gamma-oryzanol-rich rice bran oil (Vivo, Adani Wilmar) as cooking oil for 8 weeks improves blood pressure and lipid profile. In patients using a low dose of nifedipine, 20 mg daily, adding the oil blend seems to further reduce blood pressure when compared with nifedipine alone (96180).
• Menopausal symptoms. Although there is interest in using oral gamma-oryzanol for symptoms of menopause, there is insufficient reliable information about the clinical effects of gamma-oryzanol for this purpose.
• Muscle strength. It is unclear if oral gamma-oryzanol is beneficial for improving muscle strength. Details: Preliminary clinical research in well-trained male athletes over 40 years old shows that taking gamma-oryzanol 500 mg daily for 9 weeks while participating in a resistance exercise program does not improve muscle strength or vertical jump power when compared with placebo (751). Conversely, a small clinical study in young healthy males shows that taking gamma-oryzanol 600 mg daily for 9 weeks during resistance training modestly increases muscular strength when compared with placebo (100482). More evidence is needed to rate gamma-oryzanol for these uses.

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POSSIBLY SAFE ...when used orally and appropriately. Gamma-oryzanol 300 mg daily has been used most commonly in clinical research without reports of adverse events (751,752,753,754,755,51111). ...when used topically and appropriately (51112).

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

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General ...Gamma-oryzanol is generally well tolerated. No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

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