NCT00924937

CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,002 (actual)
• Sponsor: Hospital Universitario Reina Sofia de Cordoba · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

Detailed description

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: \<30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; \<10% SAT) and b) Mediterranean Diet: \>35% fat (22% MUFA; 6% PUFA ; \<10% SAT). Primary Objective: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death). Secondary Objectives: Those related in the Outcome Measures section of this webpage

Conditions

• Myocardial Infarction
• Unstable Angina
• Malignancy
• Cognitive Decline
• Diabetes Mellitus
• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean Diet	Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).
BEHAVIORAL	Low Fat Diet	Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Timeline

• Start date: 2009-11-01
• Primary completion: 2018-07-01
• Completion: 2021-05-01
• First posted: 2009-06-19
• Last updated: 2021-06-03

Locations

1 site across 1 country: Spain