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Int. J. Mol. Sci. 2017, 18(7), 1498; doi:10.3390/ijms18071498

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

1
Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy
2
Division of Endocrinology and Metabolic Diseases, Azienda Ospedaliero-Universitaria of Parma, 43126 Parma, Italy
3
Nutraceutical Research and Innovation Technology, Labomar Research, Istrana, 31036 Treviso, Italy
4
Nutraceutical Formulation, Labomar Research, Istrana, 31036 Treviso, Italy
These authors equally contributed to the paper.
*
Author to whom correspondence should be addressed.
Received: 26 May 2017 / Revised: 29 June 2017 / Accepted: 7 July 2017 / Published: 12 July 2017
(This article belongs to the Special Issue Nutraceuticals in Human Health and Disease)
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Abstract

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. View Full-Text
Keywords: nutraceuticals; non-HDL cholesterol; PCSK9; randomized clinical trial nutraceuticals; non-HDL cholesterol; PCSK9; randomized clinical trial
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Spigoni, V.; Aldigeri, R.; Antonini, M.; Micheli, M.M.; Fantuzzi, F.; Fratter, A.; Pellizzato, M.; Derlindati, E.; Zavaroni, I.; Bonadonna, R.C.; Dei Cas, A. 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. Int. J. Mol. Sci. 2017, 18, 1498.

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