Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease

NCT06701968 | Recruiting

• 1 other identifier: NORDHEART trial
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Diet can play a key role in atherosclerosis and coronary heart disease (CHD), but little interventional data exists, and the mediators of possible anti-atherosclerotic effects of diet are unclear. The investigators will investigate if a healthy Nordic diet (HND) reduces plaque volume, coronary artery calcification (CAC), and plaque inflammation (FAI) in CHD, and examine if changes in gut microbiota may be linked to plaque progression over time. The investigators will also explore if the diet response can be predicted by the metabolic phenotype. In total 150 CHD patients is randomized to a HND rich in unsaturated fat and fibre from plants, or to a "usual care diet" for 18 months. Plaque volume and composition is assessed by CT, and fecal microbiota composition is determined by deep metagenome shotgun sequencing. CHD and metabolic risk factors, liver fat, muscle fat and biomarkers of diet adherence (plasma fatty acids, whole-grain metabolites) are measured. Machine-learning is used to identify diet "responders" on plaque progression, based on the individual microbiome and metabolome. If a HND reduces plaque progression, this would be novel information of clinical importance. Also, if the diet alters microbiota that are linked to plaque progression, this would be of high scientific interest. Finally, potential prediction of the diet-response would open up for more personalized treatment of atherosclerosis.

Conditions

Coronary Disease; Coronary Arteriosclerosis; Myocardial Infarction; Chronic Coronary Syndrome; MASLD; Type 2 Diabetes

Keywords

Diet; Secondary prevention; Coronary plaque regression; Atherosclerosis; Type 2 diabetes; Coronary heart disease; Myocardial infarction; Coronary computed tomography angiography; Healthy nordic diet; NAFLD

Outcome Measures

Primary Outcomes (1)

• Change in coronary plaque volume

  Will be assessed by photon-counting CT angiography

  18 months

Secondary Outcomes (8)

• Change in coronary inflammation: Fat attenuation Index

  18 months

• To investigate if a Healthy Nordic Diet can decrease progression of atherosclerosis Change in coronary artery calcium score (CACS)

  18 months

• Change in ectopic fat (liver, heart, muscle)

  18 months

• Change in blood glycemic control

  6, 12 and 18 months

• Change in plasma LDL cholesterol

  18 months

Other Outcomes (4)

• Change in gut microbiota

  12 and 18 months

• Change in plasma inflammation proteins

  6, 12 and 18 months

• Change in plasma lipidomic profile including ceramides

  6, 12 and 18 months

Study Arms (2)

Healthy Nordic Diet

EXPERIMENTAL

Dietary advice and provided with some key food items of the healthy Nordic diet

Other: Healthy Nordic Diet

Usual care

ACTIVE COMPARATOR

Dietary advice according to standard clinical care at the cardiology unit

Behavioral: Usual Care

Interventions

Healthy Nordic Diet OTHER

Participants will be adviced a healthy Nordic diet and will also receive certain Nordic foods high in wholegrains and polyunsaturated fat from vegetable sources

Healthy Nordic Diet

Usual Care BEHAVIORAL

Usual care lifestyle advice and national and general recommendations on diet

Usual care

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Diagnosis with MI from 2 weeks after diagnosis and with maximum 6 months after diagnosis
• Diagnosis with CCS (e.g. stable angina pectoris)
• Ages 50 to 80 years
• BMI 25-40.

You may not qualify if:

• Severe heart failure (NYHA classes III, IV)
• Alcohol intake \>20g/day
• Unwillingness to follow a new prescribed diet for 18 months
• Other diseases implying a short estimated life expectancy (e.g. severe malignant or kidney or liver disease, as judged by consenting physician).

Sponsors & Collaborators

• Uppsala University: lead
• Falu Hospital: collaborator

Study Sites (1)

Cardiology clinic, Uppsala university hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Myocardial Infarction; Diabetes Mellitus, Type 2; Atherosclerosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ulf Risérus, MMED, PHD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emil Hagström, MD, PHD

CONTACT

46184710000; emil.hagstrom@ucr.uu.se

Fredrik Rosqvist, PHD

CONTACT

fredrik.rosqvist@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 30, 2031
• Last Updated: March 6, 2025

Record last verified: 2024-11

Locations

SE (1)