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

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 v...

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Main Authors: Carmela Colica, Laura Di Renzo, Domenico Trombetta, Antonella Smeriglio, Sergio Bernardini, Giorgia Cioccoloni, Renata Costa de Miranda, Paola Gualtieri, Paola Sinibaldi Salimei, Antonino De Lorenzo
Format: Article
Language:English
Published: Hindawi Limited 2017-01-01
Series:Oxidative Medicine and Cellular Longevity
Online Access:http://dx.doi.org/10.1155/2017/2473495
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spelling doaj-247423b463224c6897505f09db1b79b22020-11-25T01:11:52ZengHindawi LimitedOxidative Medicine and Cellular Longevity1942-09001942-09942017-01-01201710.1155/2017/24734952473495Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover TrialCarmela Colica0Laura Di Renzo1Domenico Trombetta2Antonella Smeriglio3Sergio Bernardini4Giorgia Cioccoloni5Renata Costa de Miranda6Paola Gualtieri7Paola Sinibaldi Salimei8Antonino De Lorenzo9CNR, IBFM UOS of Germaneto, University “Magna Graecia” of Catanzaro, Campus “Salvatore Venuta”, 88100 Germaneto, Catanzaro, ItalySection of Clinical Nutrition and Nutrigenomics, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalyDepartment of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale F. Stagno d’Alcontres 31, Messina, ItalyDepartment of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Viale F. Stagno d’Alcontres 31, Messina, ItalyDivision of Clinical Biochemistry and Clinical Molecular Biology, University of Rome Tor Vergata, Rome, ItalyPhD School of Applied Medical-Surgical Sciences, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalyPhD School of Applied Medical-Surgical Sciences, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalyPhD School of Applied Medical-Surgical Sciences, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalySection of Clinical Nutrition and Nutrigenomics, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalySection of Clinical Nutrition and Nutrigenomics, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, ItalyHydroxytyrosol (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 (p=0.001), total antioxidant status (TAS) (p=0.001), superoxide dismutase 1 (SOD1) (2−ΔΔCt = 3.7), and plasma concentration of HT (2.83 μg·mL−1) were significantly increased, while nitrite (p=0.001), nitrate (p=0.001), and malondialdehyde (MDA) (p=0.02) were drastically reduced after HTT. A significant reduction of body fat mass percentage (p=0.01), suprailiac skinfold (p=0.01), and weight (p=0.04; 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 ClinicalTrials.gov NCT01890070.http://dx.doi.org/10.1155/2017/2473495
collection DOAJ
language English
format Article
sources DOAJ
author Carmela Colica
Laura Di Renzo
Domenico Trombetta
Antonella Smeriglio
Sergio Bernardini
Giorgia Cioccoloni
Renata Costa de Miranda
Paola Gualtieri
Paola Sinibaldi Salimei
Antonino De Lorenzo
spellingShingle Carmela Colica
Laura Di Renzo
Domenico Trombetta
Antonella Smeriglio
Sergio Bernardini
Giorgia Cioccoloni
Renata Costa de Miranda
Paola Gualtieri
Paola Sinibaldi Salimei
Antonino De Lorenzo
Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
Oxidative Medicine and Cellular Longevity
author_facet Carmela Colica
Laura Di Renzo
Domenico Trombetta
Antonella Smeriglio
Sergio Bernardini
Giorgia Cioccoloni
Renata Costa de Miranda
Paola Gualtieri
Paola Sinibaldi Salimei
Antonino De Lorenzo
author_sort Carmela Colica
title Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
title_short Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
title_full Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
title_fullStr Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
title_full_unstemmed Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial
title_sort antioxidant effects of a hydroxytyrosol-based pharmaceutical formulation on body composition, metabolic state, and gene expression: a randomized double-blinded, placebo-controlled crossover trial
publisher Hindawi Limited
series Oxidative Medicine and Cellular Longevity
issn 1942-0900
1942-0994
publishDate 2017-01-01
description 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 (p=0.001), total antioxidant status (TAS) (p=0.001), superoxide dismutase 1 (SOD1) (2−ΔΔCt = 3.7), and plasma concentration of HT (2.83 μg·mL−1) were significantly increased, while nitrite (p=0.001), nitrate (p=0.001), and malondialdehyde (MDA) (p=0.02) were drastically reduced after HTT. A significant reduction of body fat mass percentage (p=0.01), suprailiac skinfold (p=0.01), and weight (p=0.04; 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 ClinicalTrials.gov NCT01890070.
url http://dx.doi.org/10.1155/2017/2473495
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