Effects evaluation of a Hydroxytyrosol-Based Pharmaceutical Formulation

Introduction Extra virgin olive oil (EVOO) is the main lipid component of Mediterranean Diet (MD). Many studies, including the Seven Country Study, demonstrated that MD is able to reduce the incidence of chronic degenerative diseases, and that integration of MD with Extra Virgin Olive Oil (EVOO) decreases the risk of major cardiovascular events. The Food and Drug Administration had recognized EVOO (23 g/day) as a qualified health claim to decrease the risk of Cardio-Vascular Diseases (CDVs). EVOO supplementation brings several benefits, due to its antioxidant, anti-inflammatory, vasodilatory, and antiplatelet aggregation properties. The main EVOO cardio-protective effect is attributable to the presence of its phenolic compounds, of which hydroxytyrosol (HT) is the main component. The European Food Safety Authority has set out the health claims related to specific EVOO phenolic compounds: "A daily intake of 5mg of HT and its derivatives protect blood lipids from oxidative stress". Based on this assumption, we hypothesized that 3 weeks administration of 15 mg/day of HT, in a gastroresistant capsules new formulation, could lead to a change in nutritional status. Methods The randomized double-blind, placebo-controlled crossover trial was conducted on 28 volunteers. Evaluation was carried out on: nutritional status, serum metabolites, biomarkers of oxidative stress and related to oxidative stress, inflammation and CVD 9 genes expression. The study consisted of 2 cycles of 3- weeks chronic treatment with HT or placebo separated by 1 week washout period. At the beginning and at the end of each treatment, body composition evaluations, gene expression, and blood analysis were performed. Results Oxidation biomarkers, total antioxidant status, SOD 1, and plasma HT concentration were significantly increased, while nitrite, nitrate and malondialdehyde, as well as percentage of fat mass, sovrailiac fold and weight were drastically reduced after treatment. Conclusions This pilot study shows that the regular intake of 15 mg/day of HT modified the parameters of body composition and modulated the antioxidant profile and inflammatory and oxidative genes expression. The results, despite the limit of the reduced number of subjects enrolled, suggest the opportunity of a personalization of the therapy. The study, repeated on a larger scale, could acquire statistical significance.