CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

NCT ID: NCT00924937

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1002 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2021-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low Fat Diet

Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids)

Group Type: ACTIVE_COMPARATOR

Low Fat Diet

Intervention Type: BEHAVIORAL

Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Mediterranean Diet

Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: BEHAVIORAL

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).

Interventions

Mediterranean Diet

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).

Intervention Type: BEHAVIORAL

Low Fat Diet

Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role: lead

Responsible Party

Francisco Perez Jimenez

Chief of Internal Medicine Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Perez-Jimenez, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Reina Sofia University Hospital

Locations

Reina Sofia University Hospital

Córdoba, , Spain

Countries

Spain

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Related Links

http://www.cordioprev.es/index.php/en/

Webpage of the study

Other Identifiers

CORDIOPREV

Identifier Type: -

Identifier Source: org_study_id