An hydroxytyrosol-based pharmaceutical formulation for the prevention of cardiovascular disease: a randomized controlled crossover trial.
Journal Title: Biomedicine & Prevention - Year 2017, Vol 2017, Issue 1
Abstract
Background and aim: Inflammation and oxidative damage contribute significantly to the development of chronic non-communicable diseases (CNCD). Hydroxytyrosol (3,4 dihydroxyphenylethanol; 3,4-DHPEA or HT), abundant in extra virgin olive oil (EVOO), plays a significant role in cardiovascular diseases (CVDs). The aim was to determine the effect in healthy volunteers of two gastro-resistant capsules containing 7.5 mg/capsule/day of HT. Methods: This clinical study was a randomized double-blinded, controlled crossover trial to determine the acute effect of two gastro-resistant capsules containing 7.5mg of HT on healthy volunteers. Evaluation of nutritional, serum metabolites, oxidative stress biomarkers and gene expression of 9 genes related to oxidative stress, inflammation and CVDs was performed. Results: Oxidative stress biomarkers, like thiols groups and total antioxidant status, were significantly increased, while nitrite and nitrate, and lipid peroxidation values were drastically reduced. Significant up-regulation of superoxide dismutase-1 was observed. These results could be associated with the significant increase in plasma concentration of HT. Conclusions: European Food Safety Authority (EFSA) scientific opinion has acknowledged the possibility to make health claims, under the provisions of Regulation EC 1924/2006, for extra virgin olive oil (EVOO) or food supplements from EVOO that provide a HT content of at least 5 mg/die in a balanced diet. This study highlights the possibility to prevent oxidative stress damages in the post prandial time, with an intake of 15 mg/day of HT, able to modulate the anti-oxidant profile and the expression of SOD1, an oxidative-stress-related gene. Chronic studies on a larger population are necessary before definitive conclusions can be drawn.
Authors and Affiliations
Laura Di Renzo, Domenico Trombetta, Antonella Smeriglio, Stefano Cascapera, Carmela Colica
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