A RANDOMIZED, PLACEBO-CONTROLLED STUDY ON THE EFFECTS OF A NUTRACEUTICAL COMBINATION OF RED YEAST RICE, SILYBUM MARIANUM AND OCTASONOL ON LIPID PROFILE, ENDOTHELIAL AND INFLAMMATORY PARAMETERS

The aim of this study was to evaluate the effects of a combination of red yeast rice, Silybum marianum and octasonol compared to placebo on lipid profile, endothelial, and inflammatory parameters in low risk dislipidemic patients. One hundred and thirty-four dislipidemic patients were randomised to take placebo or a patented nutraceutical association in tablet form (Zeta Colest (R)), 1 tablet /day (immediately after the dinner), for three months in a double-blind, placebo-controlled trial. At baseline and after 3 months the following were evaluated: body weight, body mass index (BMI), fasting plasma glucose (FPG), lipid profile, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble E-selectin (sE-selectin), metalloprotineases-2 and -9 (MMP-2 and MMP-9), high sensitivity C-reactive protein (Hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha). The nutraceutical combination decreased total cholesterol and low density lipoprotein cholesterol compared to baseline (p = 0.042, and p = 0.041, respectively) and to placebo (p = 0.039, and p = 0.037, respectively). Triglycerides were reduced by the active treatment (p = 0.039), but not by placebo, even if, in group to group comparison, no differences were recorded (p = 0.061). All adipocytokines were reduced by the nutraceutical combination, in particular p = 0.044 for sICAM-1, p = 0.045 for sVCAM-1, p = 0.040 for sE-selectin, p = 0.035 for MMP-2, p = 0.039 for MMP-9, p = 0.038 for Hs-CRP, p = 0.036 for TNF-alpha, and p = 0.036 for IL-6 compared to baseline, and p = 0.042 for sICAM-1, p = 0.043 for sVCAM-1, p = 0.042 for sE-selectin, p = 0.031 for MMP-2, p = 0.038 for MMP-9, p = 0.038 for Hs-CRP, and p = 0.043 for TNF-alpha, respectively, compared to placebo. We can conclude that a combination of red yeast rice, Silybum marianum and octasonol was effective in improving lipid profile, endothelial, and inflammatory parameters in low risk dislipidemic patients.