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

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.

Berberine and barberry (Berberis vulgaris): A clinical review

“…(−14 ± 12 mg/dl, p = 0.030), and LDL-C (−31 ± 18 mg/dl, p = 0.011) levels in comparison with the placebo (Spigoni et al, 2017).…”

“…In a double‐blind phase II placebo‐controlled study in 36 subjects, the efficacy of this nutraceutical formulation (one daily) in the reduction of cholesterol versus placebo at 12 weeks were evaluated. Results showed significant decrease of non‐HDL cholesterol (−30 ± 20 mg/dl; p = 0.012), apolipoprotein (Apo) B (−14 ± 12 mg/dl, p = 0.030), and LDL‐C (−31 ± 18 mg/dl, p = 0.011) levels in comparison with the placebo (Spigoni et al, ).…”

<p>Evaluating Risk of Incident Diabetes Between Patients Who Used Lovastatin and Red Yeast Rice Prescriptions (LipoCol Forte): A Retrospective Cohort Study Based on a Real-World Database</p>

“…30 However, the risks of diabetes or increased fasting glucose in patients who used RYR were not adequately evaluated previously. Some clinical trials used the combination of RYR and other nutraceuticals, such as garlic, berberine, 31,32 chitosan, 31 olive, 33 phytosterols, 34,35 and policosanols; 32 thus, the side effects of RYR could not be investigated independently. In addition, it is also not easy to predict or understand the side effect risks of RYR because of the high variability in monacolin content in various commercial RYR dietary supplements.…”

Phytopharmacology and Clinical Updates of Berberis Species Against Diabetes and Other Metabolic Diseases

“…Other food supplements containing BBR, including Body Lipid™, were suggested as an alternative to pharmacological treatment for patients with mild-to-moderate hypercholesterolemia (D'Addato et al, 2017). A new nutraceutical formulation containing BBR, monacolin K, chitosan, and coenzyme Q 10 has proven effective in reducing non-HDL/LDL-C levels, representing an emergent therapeutic strategy in dyslipidemic patients (Spigoni et al, 2017). On the other hand, the combination of BBR and isoflavones was found to be effective in lowering CVD risk factors in menopausal women with moderate dyslipidaemia (Cianci et al, 2012).…”