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

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ClinicalTrials.gov Identifier: NCT02938832
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Behavioral: Advice on what food to choose and eat Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CardioDiet Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Active Comparator: Traditional low-fat diet advice
Advice on traditional low-fat diet by dietician
Behavioral: Advice on what food to choose and eat
Dietary advice

Active Comparator: Mediterranean diet advice
Advice on a Mediterranean dietary regime with reduced carbohydrates
Behavioral: Advice on what food to choose and eat
Dietary advice




Primary Outcome Measures :
  1. Diabetes incidence [ Time Frame: 3 years ]
    Hba1c > 48 mmol/mol


Secondary Outcome Measures :
  1. Cardiovascular disease [ Time Frame: 3 years and more ]
    CVD incidence based on national registries

  2. Quality of Life [ Time Frame: 3 years ]
    QoL by questionnaires



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938832


Contacts
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Contact: Fredrik H Nystrom, MD professor +46101037749 ext +46 fredrik.nystrom@regionostergotland.se

Locations
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Sweden
University Hospital of Linkoping Recruiting
Linkoping, Sweden, 58185
Contact: Fredrik H Nystrom, MD, prof.         
Principal Investigator: Fredrik H Nystrom, MD PhD prof         
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
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Principal Investigator: Fredrik H Nystrom, MD professor Faculty of Medicine and Health Sciences, Linköping University

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Responsible Party: Fredrik H Nystrom, Professor, MD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02938832     History of Changes
Other Study ID Numbers: CardioDiet
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Fredrik H Nystrom, University Hospital, Linkoeping:
cardiovascular disease, diet, diabetes

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases