Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study.

Affuso F, Ruvolo A, Micillo F, Saccà L, Fazio S
Nutr Metab Cardiovasc Dis. 2010 20 (9): 656-61

PMID: 19699071 · DOI:10.1016/j.numecd.2009.05.017

BACKGROUND AND AIMS - Some nutraceuticals are prescribed as lipid-lowering substances. However, doubts remain about their efficacy. We evaluated the effects of a nutraceutical combination (NC), consisting of 500 mg berberine, 200mg red yeast rice and 10mg policosanols, on cholesterol levels and endothelial function in patients with hypercholesterolemia.

METHODS AND RESULTS - In this single centre, randomized, double-blind, placebo-controlled study, 50 hypercholesterolemic patients (26 males and 24 females, mean age 55±7 years, total cholesterol 6.55±0.75 mmol/l, BMI 28±3.5) were randomized to 6 weeks of treatment with a daily oral dose of NC (25 patients) or placebo (25 patients). In a subsequent open-label extension of 4 weeks, the whole sample received NC. The main outcome measure was decrease total cholesterol (C) levels in the NC arm. Secondary outcome measures were decreased low-density lipoprotein cholesterol (LDL-C) and triglyceride levels, and improved endothelial-dependent flow-mediated dilation (FMD) and insulin sensitivity in relation to NC. Evaluation of absolute changes from baseline showed significant reductions in NC versus placebo for C and LDL-C (C: -1.14±0.88 and -0.03±0.78 mmol/l, p<0.001; LDL-C: -1.06±0.75 and -00.4±0.54 mmol/l, p<0.001), and a significant improvement of FMD (3±4% and 0±3% respectively, p<0.05). After the extension phase, triglyceride levels decreased significantly from 1.57±0.77 to 1.26±0.63 mmol/l, p<0.05 and insulin sensitivity improved in a patient subgroup with insulin resistance at baseline (HOMA: from 3.3±0.4 to 2.5±1.3, p<0.05). No adverse effect was reported.

CONCLUSIONS - This NC reduces cholesterol levels. The reduction is associated with improved endothelial function and insulin sensitivity.

Copyright © 2009 Elsevier B.V. All rights reserved.

MeSH Terms (18)

Anticholesteremic Agents Berberine Biological Products Cholesterol Cholesterol, LDL Dietary Supplements Double-Blind Method Endothelium, Vascular Fatty Alcohols Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Insulin Resistance Male Middle Aged Placebos Triglycerides

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