A Randomized, Double Blind Clinical Study to Assess the Effects of a Gamma-oryzanol-enriched Rice Bran Oil on Lipid Profile in the Hypercholesterolemic Patients

Abstract

Background: Hypercholesterolemia is a risk factor for developing coronary artery disease. Lifestyle modification including an intake of healthy food as well as medication have approved effect in lowering serum cholesterol. Objective: The primary objective of the present study was to determine the impact of a gamma-oryzanol-enriched rice bran oil, a product of Thailand, on serum cholesterol level. Materials and Methods: A total of in 54 hypercholesterolemic patients were divided into two groups; RBOh (20,000 ppm of gammaoryzanol, n = 27), and RBOn (5,000 ppm gamma-oryzanol, n = 27). The assigned RBO (15 ml) was intake each day for 8 weeks. Fasting serum lipids were measured at baseline and at the 4th and 8th weeks of the intervention. All patients were advised about lifestyle modifications. Results: When compared to the baseline, subjects received RBOh showed a significant difference in 2 parameters including a reduction of cholesterol level at 8th weeks (p-value = 0.0101), and decrease in LDL-C level at the end of 8th weeks (p-value = 0.0013). In the group treated with RBOn, a significant increase in HDL-C level at the end of 8th weeks (p-value = 0.0303) without any effect on total cholesterol or LDL was observed. No sign of toxic effect on liver or renal functions was seen in both treatment groups. Conclusion: RBO with gamma-oryzanol-enriched could decrease cholesterol and LDL-C level in hypercholesterolemic patients. Therefore, gamma-oryzanol-enriched RBO is a functional food that may reduce cardiovascular disease risk factor. Keywords: Hypercholesterolemia, Rice bran oil, Gamma-oryzanol, Oryza sativa