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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-10-31

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.

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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.

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional low-fat diet advice

Advice on traditional low-fat diet by dietician

Group Type ACTIVE_COMPARATOR

Advice on what food to choose and eat

Intervention Type BEHAVIORAL

Dietary advice

Mediterranean diet advice

Advice on a Mediterranean dietary regime with reduced carbohydrates

Group Type ACTIVE_COMPARATOR

Advice on what food to choose and eat

Intervention Type BEHAVIORAL

Dietary advice

Interventions

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Advice on what food to choose and eat

Dietary advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No