Delgado‐Lista 2016.

Trial name or title	CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study) [NCT00924937]
Methods	RCT of parallel‐group design of 2 dietary interventions
Participants	1002 patients with CHD from Spain aged 20 to 75 years Inclusion criteria: Informed consent Clinical: unstable coronary disease with documented vessel/myocardial damage, acute myocardial infarction, revascularisation Exclusion criteria: Age < 20 or > 75 years (or life expectancy lower than 5 years) Patients already planned for revascularisation Patients submitted to revascularisation 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 2 mg/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 enrolment moment or 30 days prior)
Interventions	1) Mediterranean diet, with a minimum 35% of calories as fat (22% MUFA fat, 6% PUFA fat and < 10% saturated fat), 15% proteins and a maximum of 50% carbohydrates 2) Low‐fat high complex carbohydrate diet recommended by the National Cholesterol Education Program and the American Heart Association, comprising of < 30% total fat (< 10% saturated fat, 12% to 14% MUFA fat and 6% to 8% PUFA fat), 15% protein and a minimum 55% carbohydrates The objective was to compare the dietary pattern of the Mediterranean diet food pyramid versus the dietary pattern recommended by the American Heart Association. Both therapeutic diets should provide a wide variety of foods, including vegetables, fruit, cereals, potatoes, legumes, dairy products, meat and fish. Participants in both intervention groups receive the same intensive dietary counselling. Dietitians administered personalised individual interviews at inclusion and every 6 months, and quarterly group education sessions with up to 20 participants per session and separate sessions for each group. These sessions consisted of informative talks accompanied by written information with detailed descriptions of typical foods for each dietary pattern, seasonal shopping lists, meal plans and recipes. For those randomised to the Mediterranean diet, on the basis of the initial assessment of individual scores of adherence using a 14‐item questionnaire, dietitians gave personalised dietary advice with instructions directed to increasing the score, by including, among others, 1) abundant use of olive oil for cooking and dressing, 2) increased consumption of fruit, vegetables, legumes and fish, 3) reduction in total meat consumption, with white meat recommended instead of red or processed meat, 4) preparation of homemade sauces with tomato, garlic, onion and spices with olive oil to dress vegetables, pasta, rice and other dishes, 5) avoidance of butter, cream, fast food, sweets, pastries and sugar‐sweetened beverages, and 6) in alcohol drinkers, a moderate consumption of red wine. The participants assigned to the Mediterranean diet were given free extra‐virgin olive oil (1 litre/week). The participants randomised to the low‐fat diet received recommendations focused on limiting all types of fat, from both animal and vegetable sources, and on increasing the intake of complex carbohydrates. The participants also received free food packs incorporating the main food components of this dietary pattern. No energy restriction was administered, nor was physical activity promoted specifically by the study team. Follow‐up 7 years
Outcomes	Primary outcome: combined cardiovascular events (myocardial infarction, revascularisation, ischaemic stroke, documented peripheral artery disease or cardiovascular death) over 7‐year time frame Pre‐specified secondary outcomes are: incidence of intermittent claudication; concentration of LDL cholesterol; lipid‐related atherogenic ratios: total cholesterol/HDL and LDL/HDL; metabolic control of carbohydrates (assessed by glycaemic and insulin responses to tolerance tests to glucose); metabolic control of lipids and postprandial lipaemia; blood pressure; incidence of malignancy; incidence of type 2 diabetes mellitus; incidence of metabolic syndrome; arrhythmias; an extended composite of heart events (cardiac death, myocardial infarction, unstable angina, revascularisation, heart failure, heart transplantation and cardiac arrest), an extended composite of cardiovascular disease progression (cardiac death, myocardial infarction, unstable angina, revascularisation, heart failure, heart transplantation, cardiac arrest, stroke and peripheral artery disease), progression of cognitive decline and changes in gut microbiota
Starting date	November 2009
Contact information	Francisco Perez Jimenez, Chief of Internal Medicine Unit, Hospital Universitario Reina Sofia de Cordoba, Spain
Notes	Estimated study completion date September 2019. NCT00924937 accessed 7 October 2018.