Brief Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Cardiol. Mar 26, 2012; 4(3): 77-83
Published online Mar 26, 2012. doi: 10.4330/wjc.v4.i3.77
A nutraceutical combination improves insulin sensitivity in patients with metabolic syndrome
Flora Affuso, Valentina Mercurio, Antonio Ruvolo, Concetta Pirozzi, Filomena Micillo, Guido Carlomagno, Fabrizia Grieco, Serafino Fazio
Flora Affuso, Valentina Mercurio, Antonio Ruvolo, Concetta Pirozzi, Filomena Micillo, Guido Carlomagno, Fabrizia Grieco, Serafino Fazio, Department of Clinical Medicine, Cardiovascular and Immunological Sciences, Federico II University, 80131 Naples, Italy
Author contributions: Affuso F designed the study, selected patients, drafted the manuscript; Mercurio V followed up patients, collected and analyzed data; Ruvolo A collected and analyzed data (vascular reactivity); Pirozzi C collected and analyzed data (echocardiography); Carlomagno G analyzed and interpreted the data, drafted the manuscript; Micillo F followed up patients and collected data (provocative tests); Grieco F followed up patients, collected data; Fazio F designed the study, interpreted the data, provided final review and approval of the manuscript.
Supported by Rottapharm Madaus (Monza, Italy)
Correspondence to: Serafino Fazio, MD, Department of Clinical Medicine, Cardiovascular and Immunological Sciences, Federico II University, Via Pansini 5, 80131 Naples, Italy. fazio@unina.it
Telephone: +39-081-7463737 Fax: +39-081-7463737
Received: October 28, 2011
Revised: December 21, 2011
Accepted: December 28, 2011
Published online: March 26, 2012
Abstract

AIM: To test the efficacy of a proprietary nutraceutical combination in reducing insulin resistance associated with the metabolic syndrome (MetS).

METHODS: Sixty-four patients with MetS followed at a tertiary outpatient clinic were randomly assigned to receive either placebo or a proprietary nutraceutical combination (AP) consisting of berberine, policosanol and red yeast rice, in a prospective, double-blind, placebo-controlled study. Evaluations were performed at baseline and after 18 wk of treatment. The homeostasis model assessment of insulin resistance (HOMA-IR) index was the primary outcome measure. Secondary endpoints included lipid panel, blood glucose and insulin fasting, after a standard mixed meal and after an oral glucose tolerance test (OGTT), flow-mediated dilation (FMD), and waist circumference.

RESULTS: Fifty nine patients completed the study, 2 withdrew because of adverse effects. After 18 wk there was a significant reduction in the HOMA-IR index in the AP group compared with placebo (ΔHOMA respectively -0.6 ± 1.2 vs 0.4 ± 1.9; P < 0.05). Total and low density lipoprotein cholesterol also significantly decreased in the treatment arm compared with placebo (Δlow density lipoprotein cholesterol -0.82 ± 0.68 vs -0.13 ± 0.55 mmol/L; P < 0.001), while triglycerides, high density lipoprotein cholesterol, and the OGTT were not affected. In addition, there were significant reductions in blood glucose and insulin after the standard mixed meal, as well as an increase in FMD (ΔFMD 1.9 ± 4.2 vs 0 ± 1.9 %; P < 0.05) and a significant reduction in arterial systolic blood pressure in the AP arm.

CONCLUSION: This short-term study shows that AP has relevant beneficial effects on insulin resistance and many other components of MetS.

Keywords: Metabolic syndrome; Insulin resistance; Homeostasis model assessment index; Nutraceuticals; Berberine