Cognitive Decline, Diabetes Mellitus, Malignancy, Metabolic Syndrome, Myocardial Infarction, Unstable Angina
Conditions
Keywords
Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet
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
Interventions
BEHAVIORALMediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; \<10% SAT).
BEHAVIORALLow Fat Diet
Low fat diet: \<30% fat (12% MUFA; 6-8%PUFA; \<10% SAT)
Sponsors
Hospital Universitario Reina Sofia de Cordoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of type 2 Diabetes Mellitus | Up to Seven Years | Incidence of type 2 Diabetes Mellitus during the study |
| Inflammation and oxidative stress | Up to Seven Years | Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied |
| AGEs | Up to Seven Years | Metabolism of advanced glycation end products. |
| Mineral metabolism | Up to Seven Years | Impact of mineral metabolism on atherosclerosis |
| Echographic markers of cardiac function and clinical outcomes | Up to Seven Years | Cardiac function studies by Echocardiography at baseline and during the study |
| Microparticles | Up to Seven Years | 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 |
| Subgroup analysis | Up to Seven Years | 27\. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function |
| Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis. | Seven Years | Data from clinical and/or diagnostic tests will be analyzed |
| Concentration of LDL cholesterol. | Seven Years | Concentration of LDL cholesterol in blood samples |
| Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL. | Seven Years | Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study |
| Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c). | Seven Years | Study of the metabolism of carbohydrates during the trial |
| Blood pressure. | Seven Years | Study of blood pressure in response to the study |
| Incidence of malignancy. | Seven Years | Appearance of malignancy |
| Progression of Cognitive Decline. | Seven Years | Cognitive decline will be evaluated by validated questionnaires |
| Extended composite of cardiovascular disease progression | Seven Years | 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. |
| Extended composite of heart events | Seven Years | Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest |
| Anthropometric changes. Metabolic disease | Up to Seven Years | Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study |
| Gut Microbiota | Up to Seven Years | Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events. |
| Arrhythmias | Up to Seven Years | Study of relationship between existing or new Arrhythmias on clinical events |
| Individual evaluation of all components of the primary outcome. | Up to Seven Years | Individual apparition of hard cardiovascular events: * myocardial infarction * revascularization * ischemic stroke * documented peripheral artery disease * cardiovascular death |
| Global Metabolomics | Up to Seven Years | Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc. |
| Specific metabolomics | Up to Seven Years | Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc |
| Gene Expression | Up to Seven Years | Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc |
Other
| Measure | Time frame | Description |
|---|---|---|
| postprandial lipaemia | Up to seven years | Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables |
| Study of other Clinical events | Up to seven years | Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease |
| Subgroup Studies | Up to seven years | Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function |
| Further Studies | Up to Seven Years | Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics |
| genetics, genomics and epigenetics | Up to seven years | Influence of genetic data in the development clinical outcomes |
| Endothelial function (Flow mediated dilation) | Up to Seven Years | Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed |
Countries
Spain
Outcome results
None listed