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

Sponsor
Uppsala University
Study ID
NCT06701968
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

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
  • Usual Care — BEHAVIORAL
    Usual care lifestyle advice and national and general recommendations on diet

Study Details

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.

Key Dates

First listed
Nov 22, 2024
Start date
Mar 20, 2025
Status verified
Nov 2024
Primary completion
Jun 30, 2030
Completion
Dec 30, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Nordic Diet
    Dietary advice and provided with some key food items of the healthy Nordic diet
  • Active Comparator: Usual care
    Dietary advice according to standard clinical care at the cardiology unit

Primary Outcome Measure

Change in coronary plaque volume [ Time Frame: 18 months ]

Central Contacts

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies