810 Mol. Nutr. Food Res. 2012, 56, 810–821 DOI 10.1002/mnfr.201100673 RESEARCH ARTICLE Consumption of a grape extract supplement containing resveratrol decreases oxidized LDL and ApoB in patients undergoing primary prevention of cardiovascular disease: A triple-blind, 6-month follow-up, placebo-controlled, randomized trial Joao Tom´ e-Carneiro 1 , Manuel Gonz ´ alvez 2 , Mar Larrosa 1 , Francisco J. Garc´ ıa-Almagro 2 , Francisco Avil ´ es-Plaza 3 , Soledad Parra 3 , Mar´ ıa J. Y ´ a˜ nez-Gasc ´ on 1 , Jos ´ e A. Ruiz-Ros 2 , Mar´ ıa T. Garc´ ıa-Conesa 1 , Francisco A. Tom´ as-Barber ´ an 1 and Juan Carlos Esp´ ın 1 1 Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, Murcia, Spain 2 Cardiology Service, Morales Meseguer University Hospital, Murcia, Spain 3 Clinical Analyses Service, Virgen de La Arrixaca University Hospital, Murcia, Spain Scope: The cardioprotective role of resveratrol as part of the human diet is not yet clear. Our aim was to investigate the effect of a grape supplement containing 8 mg resveratrol in oxidized LDL (LDLox), apolipoprotein-B (ApoB), and serum lipids on statin-treated patients in primary cardiovascular disease prevention (PCP). Methods and results: A triple-blind, randomized, placebo-controlled trial was conducted. Seventy-five patients (three parallel arms) consumed one capsule (350 mg) daily for 6 months containing resveratrol-enriched grape extract (GE-RES, Stilvid R  ), grape extract (GE, similar polyphenolic content but no resveratrol), or placebo (maltodextrin). After 6 months, no changes were observed in the placebo group and only LDL cholesterol (LDLc) decreased by 2.9% (p = 0.013) in the GE group. In contrast, LDLc (−4.5%, p = 0.04), ApoB (−9.8%, p = 0.014), LDLox (−20%, p = 0.001), and LDLox/ApoB (−12.5%, p = 0.000) decreased in the Stilvid R  group, whereas the ratio non-HDLc (total atherogenic cholesterol load)/ApoB increased (8.5%, p = 0.046). No changes were observed in hepatic, thyroid, and renal function. No adverse effects were observed in any of the patients. Conclusion: This GE-RES reduced atherogenic markers and might exert additional cardiopro- tection beyond the gold-standard medication in patients from PCP. The presence of resveratrol in the GE was necessary to achieve these effects. Keywords: Cardiovascular / Clinical trial / Nutraceutical / Polyphenol / Resveratrol Received: October 7, 2011 Revised: January 3, 2012 Accepted: January 9, 2012 1 Introduction Cardiovascular diseases (CVDs) are the leading cause of death globally. According to the World Health Organization (WHO), an estimated 17.1 million people died from CVDs Correspondence: Dr. Juan Carlos Esp´ ın, Research Group on Qual- ity, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS-CSIC, P.O. Box 164, 30100 Cam- pus de Espinardo, Murcia, Spain E-mail: jcespin@cebas.csic.es Fax: +34-968-396213 in 2004 (29% of all global deaths). Unfortunately, these esti- mations will be even worse since by 2030 almost 24 million people will die from CVDs according to WHO. However, despite these data, results of long-term prospective studies identify low risk factors in people having healthy lifestyles Abbreviations: ApoB, apolipoprotein B; GE, grape extract; GE- RES, resveratrol-enriched grape extract (Stilvid R  ); HED, human equivalent dose; LDLox, oxidized low-density lipoprotein; non- HDLc, whole atherogenic fraction of cholesterol (Tchol–LDLc); PCP, primary cardiovascular disease prevention; Tchol, total cholesterol C  2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim www.mnf-journal.com