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


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.
Affuso
F
F
Department of Internal Medicine, Cardiovascular and Immunologic Sciences, University of Naples Federico II, Naples, Italy.
Ruvolo
A
A
Micillo
F
F
Saccà
L
L
Fazio
S
S
D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D001599:Berberine / Q000008:administration & dosage*; D001688:Biological Products / Q000008:administration & dosage*; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D004730:Endothelium, Vascular / Q000503:physiopathology*; D005233:Fatty Alcohols / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000503:physiopathology; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014280:Triglycerides / Q000097:blood
D000924:Anticholesteremic Agents; D001688:Biological Products; D008078:Cholesterol, LDL; D005233:Fatty Alcohols; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010919:Placebos; D014280:Triglycerides; C117343:red yeast rice; D001599:Berberine; C080710:policosanol; D002784:Cholesterol