|Support type:||Scholarships in Brazil - Scientific Initiation|
|Effective date (Start):||April 01, 2012|
|Effective date (End):||March 31, 2013|
|Field of knowledge:||Health Sciences - Nutrition - Nutrition Biochemistry|
|Principal Investigator:||Inar Castro Erger|
|Home Institution:||Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil|
Cardiovascular diseases (CVD) are major causes of morbidity and mortality in industrialized countries and developing countries. Among these stands out as atherosclerosis, an inflammatory disease of multifactorial origin that occurs in response to endothelial aggression, which is the main pathological process that leads to coronary heart disease and cerebral vascular disease. A risk factor for early atherosclerotic plaque formation is the elevation of atherogenic lipoproteins such as LDL, IDL and VLDL, and many strategies have been used to decrease these molecules. Association of drugs such as statins and ezetimibe, and with these bioactive compounds such as phytosterols, have been extensively researched in an attempt to potentiating of hypocholesterolemic effects in the reduction of side effects caused by medications, the reduction of oxidative stress and risk of developing diseases chronic. However, the combination of drugs with bioactive compounds is still little used in clinical practice under the argument that comparative studies are still lacking. Thus, the objective of this study will compare the combination of lipid-lowering therapies, "statins + ezetimibe" and "+ phytosterols statin" on lipid profile, oxidative stress and inflammatory parameters of subjects with metabolic syndrome, with the hypothesis that association of statin is effective both with phytosterols as with ezetimibe in lowering total cholesterol and LDL and thus decreasing the oxidative stress, and the use of bioactive compound would have the advantage of being a natural product present in foods, which would imply a greater adherence when compared to the drug. The study will consist of two stages. In the first phase will be produced chocolates diet by adding 1 to 2 g of phytosterols / unit, was selected this product as the food matrix by its lipid content, important for the solubility of phytosterols, and because it is a widely accepted food. These chocolates will be analyzed for stability every 15 days during 3 months by evaluating physical, chemical, microbiological and sensory properties. In the second phase will be conducted a clinical cross-over double-blind for 6 weeks, with approximately 50 patients with metabolic syndrome with controlled dyslipidemia with statins, receiving ezetimibe or phytosterols in two different periods. In addition to analysis of lipid profile (total cholesterol, LDL, HDL and triglycerides) will be evaluated the effect of double therapy on biomarkers of oxidative stress (malondialdehyde, activity and expression of catalase, superoxide dismutase, glutathione peroxidase, total antioxidant activity, oxidized LDL) and inflammatory parameters (IL-6, TNF-a, adiponectin, leptin, CRP).