Clinical trial NCT00924937: CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Unstable Angina
Malignancy
Cognitive Decline
Diabetes Mellitus
Metabolic Syndrome
Keywords: Cardiovascular events
Blood pressure
Incidence of Cancer
Cognitive decline
Mediterranean Diet
Secondary Prevention
Low fat diet
Lead sponsor: Hospital Universitario Reina Sofia de Cordoba
Sponsor class: OTHER_GOV
First posted: 2009-06-19
Enrollment: 1002
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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).

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.
timeFrame: Seven Years
Secondary outcomes:
measure: Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
timeFrame: Seven Years
measure: Concentration of LDL cholesterol.
timeFrame: Seven Years
measure: Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
timeFrame: Seven Years
measure: Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
timeFrame: Seven Years
measure: Blood pressure.
timeFrame: Seven Years
measure: Incidence of malignancy.
timeFrame: Seven Years
measure: Progression of Cognitive Decline.
timeFrame: Seven Years
measure: Extended composite of cardiovascular disease progression
timeFrame: Seven Years
measure: Extended composite of heart events
timeFrame: Seven Years
measure: Incidence of type 2 Diabetes Mellitus
timeFrame: Up to Seven Years
measure: Anthropometric changes. Metabolic disease
timeFrame: Up to Seven Years
measure: Gut Microbiota
timeFrame: Up to Seven Years
measure: Arrhythmias
timeFrame: Up to Seven Years
measure: Individual evaluation of all components of the primary outcome.
timeFrame: Up to Seven Years
measure: Global Metabolomics
timeFrame: Up to Seven Years
measure: Specific metabolomics
timeFrame: Up to Seven Years
measure: Gene Expression
timeFrame: Up to Seven Years
measure: Inflammation and oxidative stress
timeFrame: Up to Seven Years
measure: AGEs
timeFrame: Up to Seven Years
measure: Mineral metabolism
timeFrame: Up to Seven Years
measure: Echographic markers of cardiac function and clinical outcomes
timeFrame: Up to Seven Years
measure: Microparticles
timeFrame: Up to Seven Years
measure: Subgroup analysis
timeFrame: Up to Seven Years
Other outcomes:
measure: Endothelial function (Flow mediated dilation)
timeFrame: Up to Seven Years
measure: genetics, genomics and epigenetics
timeFrame: Up to seven years
measure: postprandial lipaemia
timeFrame: Up to seven years
measure: Study of other Clinical events
timeFrame: Up to seven years
measure: Subgroup Studies
timeFrame: Up to seven years
measure: Further Studies
timeFrame: Up to Seven Years
Locations:
city: Cordoba
country: Spain
facility: Reina Sofia University Hospital
Study officials:
affiliation: Reina Sofia University Hospital
name: Francisco Perez-Jimenez, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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