Long-term efficacy and tolerability of a multicomponent lipid-lowering nutraceutical in overweight and normoweight patients

• Published in: Nutrafoods Vol. 11; no. 2; pp. 55 - 61
• Main Authors: Cicero, Arrigo F. G., De Sando, Valeria, Benedetto, Danilo, Cevenini, Matteo, Grandi, Elisa, Borghi, Claudio
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 01.06.2012
• Subjects: Chemistry; Chemistry and Materials Science; Clinical Nutrition; Food Science; Nutrition; Original Research; policosanol; hypolipidaemic; monakoline; hypoglycaemic; HOMA index; berberine
• ISSN: 1827-8590; 2240-5291
• DOI: 10.1007/s13749-012-0018-y

The short-term lipid-lowering activity of some nutraceuticals is well known, however there is a lack of knowledge about their long-term effect, especially regarding insulin-resistance parameters and biomarkers of vascular health. This study is a 12-month follow-up randomised clinical trial carried out on 269 non-smoker hyperlipidaemic patients in primary prevention for cardiovascular disease; 214 of them (129 men and 85 women) completed the trial with good compliance. None of the subjects were diabetics or had been treated with antihyperlipidaemic drugs. Seventy-nine normoweight subjects (Group 1) were treated with a combined nutraceutical monakolinberberine-policosand (MBP) mixture associated with a standardised therapeutic lifestyle (TLS) (as defined in the third Adult Treatment Panel of the National Cholesterol Education Program), 85 overweight subjects were treated with MBP-TLS (Group 2) and 50 overweight subjects only with intensified TLS (Group 3). Efficacy parameters (Body Mass Index, fasting plasma glucose, fasting plasma insulin, Homeostasis Model Assessment index, metalloproteinase-2 (MMP-2), MMP-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), TIMP-2, total cholesterol, low-density lipoprotein-C, high-density lipoprotein-C, triglyceride) were evaluated every 4 months. Educational reinforcements were also planned every 4 months. This study demonstrated the long-term efficacy and safety of a combined nutraceutical added to a TLS in overweight and normoweight dyslipidaemic subjects. Berberine- and red yeast rice-based nutraceuticals showed efficacy in body weight reduction and insulin-sensitivity promotion in non-diabetic hyperlipidaemic patients. Favourable effects of a combined nutraceutical in combination with a TLS were observed on biomarkers of vascular remodelling in overweight and normoweight dyslipidaemic subjects.