Does the Advice to Eat a Mediterranean Diet With Low Carbohydrate Intake, Compared With a Low-fat Diet, Reduce Diabetes and Cardiovascular Disease?

Study Overview
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Brief Summary
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This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.

Detailed Description
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Aim To compare advice on a Mediterranean diet with an energy content (E%) from carbohydrates between 25-30 E% with a traditional low-fat diet with 45-60 E% from carbohydrates. Primary outcome Incidence of diabetes in non-diabetic patients or glycaemic control in patients with known diabetes. Secondary outcome Recurrence of cardiovascular disease, blood lipid levels, quality of life by questionnaires. Study design and study population This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.

Official Title
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The CardioDiet Trial

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Behavioral: Advice on what food to choose and eat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated for ischemic heart disease who are followed up at the cardiac rehabilitation units Exclusion Criteria: Inability to affect food choice. Severe concomitant disease such as malignancy, renal failure, heart failure or psychiatric disease.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional low-fat diet advice<br>Advice on traditional low-fat diet by dietician | Behavioral: Advice on what food to choose and eat<br>* Dietary advice<br>|
| Active Comparator: Mediterranean diet advice<br>Advice on a Mediterranean dietary regime with reduced carbohydrates | Behavioral: Advice on what food to choose and eat<br>* Dietary advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes incidence | Hba1c > 48 mmol/mol | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease | CVD incidence based on national registries | 3 years and more | 
| Quality of Life | QoL by questionnaires | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, diet, diabetes