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Clinical Trials in Sweden / NCT06701968
Recruiting Not applicable

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

NCT06701968 · tracked via the Priya Life Science Sweden tracker
Sponsor
Uppsala University
Phase
Not applicable
Started
2025-03-20
Last updated
2025-03-06

Condition(s) studied

Coronary DiseaseCoronary ArteriosclerosisMyocardial InfarctionChronic Coronary SyndromeMASLDType 2 Diabetes

Investigational drug(s) / intervention(s)

Healthy Nordic DietUsual Care

Healthy Nordic Diet: 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: Usual care lifestyle advice and national and general recommendations on diet

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Primary outcome measure(s)

  • Change in coronary plaque volume — 18 months
    Will be assessed by photon-counting CT angiography

Trial sites (1)

FacilityCityRegionStatus
Cardiology clinic, Uppsala university hospital Uppsala Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06701968 on ClinicalTrials.gov ↗ ← All trials in Sweden