Giuseppe Derosa^{1, 2,}, Giovanni Gaudio³, Angela D’Angelo^{1, 2}, Pamela Maffioli¹

The aim of this study was to evaluate, in hypercholesterolemic patients, the effects on lipid profile both at fasting and after an oral fat load (OFL), of 3 months of treatment with a nutraceutical combination containing monacolin K, Cynara scolymus, Thea sinensis L., Oryza sativa L., Brassica campestris L., folic acid, coenzyme Q10, and Resveratrol compared to placebo. We enrolled 63 Caucasian patients, aged ≥18 of either sex, at low cardiovascular risk (≤ 2%) and randomized them to take the nutraceutical or placebo for 3 months. We evaluated fasting plasma glucose, lipid profile, high sensitivity C-reactive protein and safety parameters at baseline and after 3 months. Patients also underwent an OFL at baseline and at the end of the study. Nutraceutical combination gave a reduction of total cholesterol (TC), triglycerides (Tg), and low-density lipoprotein-cholesterol (LDL-C), both compared to baseline (p < 0.05), and compared to placebo (p < 0.05). High-sensitivity C-reactive protein decreased in the active group both compared to baseline and to placebo (p < 0.05 for both). During the OFL performed at the end of the study, TC, and LDL-C recorded in the group treated with the nutraceutical combination were lower compared to the values recorded during the baseline OFL (p < 0.05), and also compared to values recorded in placebo group (p< 0.01) at every time of OFL. Regarding Tg, the value recorded during the OFL at the end of the study was lower at 6 hours compared to baseline OFL (p < 0.05 vs baseline), and to placebo (p < 0.05). A nutraceutical containing monacolin K, Cynara scolymus, Thea sinensis L., Oryza sativa L., Brassica campestris L., folic acid, coenzyme Q10, and Resveratrol could be helpful in improving lipid profile in hypercholesterolemic patients, both at fasting and in post-prandial phase.

Monascus purpureus, Cynara scolymus, Thea sinensis L., Oryza sativa L., Brassica campestris L., polygenic hypercholesterolemia