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Oxidative Medicine and Cellular Longevity
Volume 2017, Article ID 2473495, 14 pages
Clinical Study

Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial

1CNR, IBFM UOS of Germaneto, University “Magna Graecia” of Catanzaro, Campus “Salvatore Venuta”, 88100 Germaneto, Catanzaro, Italy
2Section of Clinical Nutrition and Nutrigenomics, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
3Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale F. Stagno d’Alcontres 31, Messina, Italy
4Division of Clinical Biochemistry and Clinical Molecular Biology, University of Rome Tor Vergata, Rome, Italy
5PhD School of Applied Medical-Surgical Sciences, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy
6CAPES Scholarship (Proc No. BEX 13264/13-3), CAPES Foundation, Ministry of Education of Brazil, 70040-020 Brasília, DF, Brazil

Correspondence should be addressed to Laura Di Renzo;

Received 3 May 2017; Accepted 19 June 2017; Published 9 August 2017

Academic Editor: Fabio Galvano

Copyright © 2017 Carmela Colica et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Hydroxytyrosol (HT) plays a significant role in cardiovascular disease (CVD) protection, and its metabolites are able to protect from the endothelial dysfunction commonly present in atherosclerosis. This randomized double-blinded, placebo-controlled crossover trial determined the effect in healthy volunteers of two gastroresistant capsules containing 15 mg/day of HT, for a 3-week period (HTT). Evaluation of nutritional status, serum metabolites, oxidative stress biomarkers, and gene expression of 9 genes related to oxidative stress, inflammation, and CVDs was performed. Oxidation biomarkers like thiol group (), total antioxidant status (TAS) (), superoxide dismutase 1 (SOD1) (2−ΔΔCt = 3.7), and plasma concentration of HT (2.83 μg·mL−1) were significantly increased, while nitrite (), nitrate (), and malondialdehyde (MDA) () were drastically reduced after HTT. A significant reduction of body fat mass percentage (), suprailiac skinfold (), and weight (; Δ% = −0.46%) was observed after HTT. This study shows that regular intake of 15 mg/day of HT changed body composition parameters and modulated the antioxidant profile and the expression of inflammation and oxidative stress-related genes. However, it is advisable to personalize HT doses in order to exert its health benefits in CVD prevention and protection of LDL-C particles from oxidative damage. This trial is registered with NCT01890070.