Overview

This trial is active, not recruiting.

Conditions myocardial infarction, unstable angina, malignancy, cognitive decline, diabetes mellitus, metabolic syndrome
Treatments mediterranean diet, low fat diet
Sponsor Hospital Universitario Reina Sofia
Start date November 2009
End date February 2019
Trial size 1002 participants
Trial identifier NCT00924937, CORDIOPREV

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Active Comparator)
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
low fat diet Dieta Baja en grasas
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
(Experimental)
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
mediterranean diet Dieta Mediterranea
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Primary Outcomes

Measure
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
time frame: Seven Years

Secondary Outcomes

Measure
Incidence of intermittent claudication.
time frame: Seven Years
Concentration of LDL cholesterol.
time frame: Seven Years
Atherogenic ratio Total cholesterol/HDL and LDL/HDL.
time frame: Seven Years
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose).
time frame: Seven Years
Blood pressure.
time frame: Seven Years
Incidence of malignancy.
time frame: Seven Years
Progression of Cognitive Decline.
time frame: Seven Years
Extended composite of cardiovascular disease progression
time frame: Seven Years
Extended composite of heart events
time frame: Seven Years
Incidence of type 2 Diabetes Mellitus
time frame: Up to Seven Years
Incidence of Metabolic Syndrome
time frame: Up to Seven Years
Composition of the different families of Gut Microbiota
time frame: Up to Seven Years

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Informed Consent - Clinical: Unstable coronary disease with documented vessel/myocardial damage - Acute Myocardial Infarction - Revascularization Exclusion Criteria: - Age < 20 or > 75 years (or life expectancy lower than 5 years). - Patients already planned for revascularization. - Patients submitted to revascularization in the last 6 months - Grade II-IV Heart failure. - Left ventricle dysfunction with ejection fraction lower than 35%. - Patients unable to follow a protocol. - Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus. - Other chronic diseases: - Psychiatric diseases - Renal Insufficiency - Chronic Hepatopathy - Active Malignancy - Chronic obstructive pulmonary disease - Diseases of the digestive tract Endocrine disorders - Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).

Additional Information

Official title Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
Principal investigator Francisco Perez-Jimenez, MD,PhD
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; 6-8% polyunsaturated fatty acid ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acid ; <10% SAT). Primary Objective: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. Secondary Objectives: Those related in the Outcome Measures section of this webpage
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hospital Universitario Reina Sofia.