Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study.

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m²) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (-30 ± 20 mg/dL; p = 0.012), LDL cholesterol (-31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (-14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.
Competing Interests: Valentina Spigoni, Federica Fantuzzi, Eleonora Derlindati, Maria Maddalena Micheli, Monica Antonini, Monica Antonini, and Ivana Zavaroni have no disclosures. Alessandra Dei Cas is an invited speaker for Doc generic, Merck Sharp & Dohme, Astra Zeneca, Sanofi, Eli Lilly Ltd., and consultant to Eli Lilly Ltd. and Boeringher. Riccardo C. Bonadonna is a member of the following board/advisory panel: MSD, Eli Lilly Ltd., Amgen, Sanofi and invited speaker for Sanofi, MSD, Bristol-Myers Squibb, Eli Lilly Ltd, Astra Zeneca, Janssen. Andrea Fratter is the head of the Research and Innovation Technology Department in Labomar, the company that has developed and patented Coleosoma, the main technological matrix employed in the clinical test. Marzia Pellizzato is the head of the Nutraceutical Formulation Department in Labomar, the company that has developed and patented Coleosoma, the main technological matrix employed in the clinical test. The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.