CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline, Diabetes Mellitus, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Mediterranean Diet
* Behavioral: Low Fat Diet


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Fat Diet<br>Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids) | Behavioral: Low Fat Diet<br>* Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)<br>|
| Experimental: Mediterranean Diet<br>Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids). | Behavioral: Mediterranean Diet<br>* Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Seven Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis. | Data from clinical and/or diagnostic tests will be analyzed | Seven Years | 
| Concentration of LDL cholesterol. | Concentration of LDL cholesterol in blood samples | Seven Years | 
| Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL. | Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study | Seven Years | 
| Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c). | Study of the metabolism of carbohydrates during the trial | Seven Years | 
| Blood pressure. | Study of blood pressure in response to the study | Seven Years | 
| Incidence of malignancy. | Appearance of malignancy | Seven Years | 
| Progression of Cognitive Decline. | Cognitive decline will be evaluated by validated questionnaires | Seven Years | 
| Extended composite of cardiovascular disease progression | 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. | Seven Years | 
| Extended composite of heart events | Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest | Seven Years | 
| Incidence of type 2 Diabetes Mellitus | Incidence of type 2 Diabetes Mellitus during the study | Up to Seven Years | 
| Anthropometric changes. Metabolic disease | Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study | Up to Seven Years | 
| Gut Microbiota | Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events. | Up to Seven Years | 
| Arrhythmias | Study of relationship between existing or new Arrhythmias on clinical events | Up to Seven Years | 
| Individual evaluation of all components of the primary outcome. | Individual apparition of hard cardiovascular events: myocardial infarction revascularization ischemic stroke documented peripheral artery disease cardiovascular death | Up to Seven Years | 
| Global Metabolomics | Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc. | Up to Seven Years | 
| Specific metabolomics | Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc | Up to Seven Years | 
| Gene Expression | Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc | Up to Seven Years | 
| Inflammation and oxidative stress | Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied | Up to Seven Years | 
| AGEs | Metabolism of advanced glycation end products. | Up to Seven Years | 
| Mineral metabolism | Impact of mineral metabolism on atherosclerosis | Up to Seven Years | 
| Echographic markers of cardiac function and clinical outcomes | Cardiac function studies by Echocardiography at baseline and during the study | Up to Seven Years | 
| Microparticles | Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry | Up to Seven Years | 
| Subgroup analysis | 27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function | Up to Seven Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet