BRIEF ARTICLE 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, Seraino Fazio Flora Affuso, Valentina Mercurio, Antonio Ruvolo, Con- cetta Pirozzi, Filomena Micillo, Guido Carlomagno, Fabrizia Grieco, Serafino Fazio, Department of Clinical Medicine, Cardiovascular and Immunological Sciences, Federico Ⅱ Uni- versity, 80131 Naples, Italy Author contributions: Affuso F designed the study, selected patients, drafted the manuscript; Mercurio V followed up pa- tients, 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 fol- lowed up patients, collected data; Fazio F designed the study, interpreted the data, provided inal review and approval of the manuscript. Supported by Rottapharm Madaus (Monza, Italy) Correspondence to: Serafino Fazio, M�, Serafino Fazio, M�, Department of Clinical Medicine, Cardiovascular and Immunological Sci- ences, 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 eficacy 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, policosa- nol and red yeast rice, in a prospective, double-blind, placebo-controlled study. Evaluations were performed at baseline and after 18 wk of treatment. The homeo- stasis model assessment of insulin resistance (HOMA- IR) index was the primary outcome measure. Second- ary endpoints included lipid panel, blood glucose and insulin fasting, after a standard mixed meal and after an oral glucose tolerance test (OGTT), low-mediated dilation (FM�), and waist circumference. RESULTS: Fifty nine patients completed the study, 2 withdrew because of adverse effects. After 18 wk there was a signiicant 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 den- sity lipoprotein cholesterol also signiicantly 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 signiicant 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 signiicant reduction in arterial systolic blood pressure in the AP arm. CONCLUSION: This short-term study shows that AP has relevant beneicial effects on insulin resistance and many other components of MetS. © 2012 Baishideng. All rights reserved. Key words: Metabolic syndrome; Insulin resistance; Homeostasis model assessment index; Nutraceuticals; Berberine Peer reviewer: Hiroki Teragawa, MD, PhD, Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical Sciences, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan Affuso F, Mercurio V, Ruvolo A, Pirozzi C, Micillo F, Carlo- magno G, Grieco F, Fazio S. A nutraceutical combination im- proves insulin sensitivity in patients with metabolic syndrome. World J Cardiol 2012; 4(3): 77-83 Available from: URL: http:// www.wjgnet.com/1949-8462/full/v4/i3/77.htm DOI: http:// dx.doi.org/10.4330/wjc.v4.i3.77 77 March 26, 2012|Volume 4|Issue 3| WJC|www.wjgnet.com Online Submissions: http://www.wjgnet.com/���������o��ce ���������o��ce o��ce wjc@wjgnet.com doi:10.4330�wjc.�4.i3.77 10.4330�wjc.�4.i3.77 �wjc.�4.i3.77 World J ��rd�ol ��rd�ol 2012 March 26; 4(3): 77-83 ISSN 1�4�-8462 (online) 1�4�-8462 (online) (online) © 2012 Baishideng. All rights reser�ed. World Journ�l of Cardiology WJC