Effect of a food supplement containing berberine, monacolin K, hydroxytyrosol and coenzyme Q on lipid levels: a randomized, double-blind, placebo controlled study.

Purpose: To evaluate the ability of the new food supplement, Body Lipid (BL), containing red yeast rice, berberine, coenzyme Q and hydroxytyrosol, to lower the LDL-C in patients with mild-to-moderate hypercholesterolemia and to assess the overall safety profile of the product.

Methods: In this multicenter, randomized, double-blind, placebo and active comparator (the marketed Armolipid Plus [AM]) controlled study, 158 hypercholesterolemic patients were randomized following a 4-week dietary run-in period. After 4 weeks of treatment with a daily oral dose of the new food supplement BL, AM or placebo, plus diet, the main outcome was the decrease of LDL-C, total cholesterol (TC), and triglyceride levels.