Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
Randomized clinical trial involving 874 patients with coronary disease that will undergo one
of two diets in a randomized design (two groups of 437 patients each) for 5 years. The two
diets will be: a)Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT) and b) Mediterranean Diet:
34% fat (22% MUFA; 6% PUFA; 7% SAT).
Primary Objective: To compare the effects of the two dietary patterns on the incidence of
cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac
transplant, stroke, symptomatic heart failure, or any other clinical manifestation of
cardiovascular event after 5 years.
- To compare the incidence of intermittent claudication.
- To compare the concentration of LDL cholesterol.
- To compare the atherogenic ratio Total cholesterol/HDL and LDL/HDL.
- To compare the metabolic control of carbohydrates (assessed by glycemic and insulin
responses to intravenous tolerance test to glucose).
- To compare blood pressure.
- To compare the response to ergometry tests.
- To compare the incidence of Cancer.
- To compare the cognitive decline.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.
Francisco Perez-Jimenez, MD,PhD
Reina Sofia University Hospital
Spain: Ethics Committee