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

Ischemic Heart Disease Clinical Trial

Official title:

The CardioDiet Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938832
• Other study ID #: CardioDiet
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: October 2023

Study information

• Verified date: April 2019
• Source: University Hospital, Linkoeping
• Contact: Fredrik H Nystrom, MD professor
• Phone: +46101037749
• Email: fredrik.nystrom[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2023
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Advice on what food to choose and eat
Dietary advice

Locations

Country	Name	City	State
Sweden	University Hospital of Linkoping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes incidence	Hba1c > 48 mmol/mol	3 years
Secondary	Cardiovascular disease	CVD incidence based on national registries	3 years and more
Secondary	Quality of Life	QoL by questionnaires	3 years