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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?

The CardioDiet Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02938832
Enrollment
1200
Registered
2016-10-19
Start date
2016-10-31
Completion date
2023-10-31
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

cardiovascular disease, diet, diabetes

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.

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.

Interventions

BEHAVIORALAdvice on what food to choose and eat

Dietary advice

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetes incidence3 yearsHba1c \> 48 mmol/mol

Secondary

MeasureTime frameDescription
Cardiovascular disease3 years and moreCVD incidence based on national registries
Quality of Life3 yearsQoL by questionnaires

Countries

Sweden

Contacts

Primary ContactFredrik H Nystrom, MD professor
fredrik.nystrom@regionostergotland.se+46101037749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026