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

Autor: Eleonora Derlindati, Maria Maddalena Micheli, Monica Antonini, Ivana Zavaroni, Alessandra Dei Cas, Andrea Fratter, Valentina Spigoni, Raffaella Aldigeri, Federica Fantuzzi, Riccardo R.C. Bonadonna, Marzia Pellizzato
Jazyk: angličtina
Rok vydání: 2017
Předmět:
0301 basic medicine
Male
Chitosan -- therapeutic use
Apolipoprotein B
Berberine
Cholesterol -- blood
030204 cardiovascular system & hematology
PCSK9
lcsh:Chemistry
chemistry.chemical_compound
0302 clinical medicine
Medicine
lcsh:QH301-705.5
Spectroscopy
nutraceuticals
Biological Products -- therapeutic use
biology
General Medicine
Sciences bio-médicales et agricoles
Middle Aged
Computer Science Applications
Cholesterol
Female
lipids (amino acids
peptides
and proteins)
Proprotein Convertase 9
Adult
medicine.medical_specialty
Drug Compounding
Placebo
Catalysis
Article
Inorganic Chemistry
03 medical and health sciences
Internal medicine
Red yeast rice
Humans
Physical and Theoretical Chemistry
Dyslipidemias -- blood -- drug therapy
non-HDL cholesterol
Molecular Biology
Dyslipidemias
Aged
Biological Products
Chitosan
business.industry
Organic Chemistry
randomized clinical trial
Proprotein Convertase 9 -- metabolism
medicine.disease
Non-HDL cholesterol
Nutraceuticals
Randomized clinical trial
030104 developmental biology
Endocrinology
chemistry
lcsh:Biology (General)
lcsh:QD1-999
biology.protein
Creatine kinase
Berberine -- therapeutic use
business
Dyslipidemia
Lipoprotein
Zdroj: International Journal of Molecular Sciences, Vol 18, Iss 7, p 1498 (2017)
International Journal of Molecular Sciences; Volume 18; Issue 7; Pages: 1498
International journal of molecular sciences, 18 (7
International Journal of Molecular Sciences
ISSN: 1422-0067
Popis: 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.
info:eu-repo/semantics/published
Databáze: OpenAIRE
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