An open-label study on the short-term effects of a novel EFSA-compliant nutraceutical combination in mild-to-moderate hypercholesterolemia

Objective: Recently, the European Food Safety Authority (EFSA) has recommended to limit the use of total monacolins in red yeast rice (RYR) products to a dose <۳ mg/day. However, data concerning the lipid lowering efficacy of the reduced dosage remain limited. A monacolin dose reduced due to safety issues may be expected to be less effective as a lipid lowering strategy and, for this reason, nutraceutical combinations with other active compounds may offer a viable solution as they can act synergistically through different mechanisms.Materials and Methods: This ۸-week open-label study was designed to investigate the safety and efficacy of a novel ESFA-compliant lipid lowering nutraceutical combination (Colestarmony Plus®; containing total monacolins from RYR at a dose of ۲.۹ mg/day, a highly bioavailable berberine formulation, and pomegranate extract) in subjects (n=۴۰) with mild-to-moderate hypercholesterolemia and no history of cardiovascular disease.Results: After ۸ weeks of supplementation, Colestarmony Plus® significantly reduced total cholesterol (−۱۰.۴%, p<۰.۰۵), low-density lipoprotein cholesterol (−۱۴.۸%, p<۰.۰۵), oxidized low-density lipoprotein cholesterol (−۱۲.۰%, p<۰.۰۵), and high-sensitivity C-reactive protein (−۱۴.۰%, p<۰.۰۵) compared with baseline values. A subgroup of ۲۲ patients underwent measurements of flow-mediated dilation, with values increasing by ۱۸.۰% at ۸ weeks with respect to baseline (p<۰.۰۵). The supplement was generally well-tolerated.Conclusion: Our short-term results indicate that the tested ESFA-compliant nutraceutical is effective in a primary prevention setting, even by providing only <۳ mg/day of monacolins.

Keywords:

Monacolins , Berberine , Pomegranate , Nutraceutical , Hypercholesterolemia , Primary prevention