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Abstract: 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 500mg 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±0.75mmol/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±0.78mmol/l, p <0.001; LDL-C: −1.06±0.75 and −00.4±0.54mmol/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±0.63mmol/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. [ABSTRACT FROM AUTHOR]