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

NCT02938832 | Unknown Phase 4

• 1 other identifier: CardioDiet
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Keywords

cardiovascular disease, diet, diabetes

Outcome Measures

Primary Outcomes (1)

• Diabetes incidence

  Hba1c \> 48 mmol/mol

  3 years

Secondary Outcomes (2)

• Cardiovascular disease

  3 years and more

• Quality of Life

  3 years

Study Arms (2)

Traditional low-fat diet advice

ACTIVE COMPARATOR

Advice on traditional low-fat diet by dietician

Behavioral: Advice on what food to choose and eat

Mediterranean diet advice

ACTIVE COMPARATOR

Advice on a Mediterranean dietary regime with reduced carbohydrates

Behavioral: Advice on what food to choose and eat

Interventions

Advice on what food to choose and eat BEHAVIORAL

Dietary advice

Mediterranean diet advice; Traditional low-fat diet advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Cardiovascular Diseases; Diabetes Mellitus

Interventions

Eating

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Fredrik H Nystrom, MD professor

  Faculty of Medicine and Health Sciences, Linköping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik H Nystrom, MD professor

CONTACT

+46101037749; fredrik.nystrom@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2023
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)