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.

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 / Spigoni, Valentina; Aldigeri, Raffaella; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo; DEI CAS, Alessandra. - In: INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES. - ISSN 1661-6596. - 18:7(2017), p. 1498. [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

Aldigeri, Raffaella;BONADONNA, Riccardo;DEI CAS, Alessandra
2017

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.
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 / Spigoni, Valentina; Aldigeri, Raffaella; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo; DEI CAS, Alessandra. - In: INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES. - ISSN 1661-6596. - 18:7(2017), p. 1498. [10.3390/ijms18071498]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2832521
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