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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional low-fat diet advice | Active Comparator | Advice on traditional low-fat diet by dietician |
|
| Mediterranean diet advice | Active Comparator | Advice on a Mediterranean dietary regime with reduced carbohydrates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advice on what food to choose and eat | Behavioral | Dietary advice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes incidence | Hba1c > 48 mmol/mol | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular disease | CVD incidence based on national registries | 3 years and more |
| Quality of Life | QoL by questionnaires | 3 years |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrik H Nystrom, MD professor | Contact | +46101037749 | +46 | fredrik.nystrom@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Fredrik H Nystrom, MD professor | Faculty of Medicine and Health Sciences, Linköping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Linkoping | Recruiting | Linköping | 58185 | Sweden |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004435 | Eating |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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