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

Recruiting now · Not applicable

Conditions studied: Coronary Disease, Coronary Arteriosclerosis, Myocardial Infarction, Chronic Coronary Syndrome, MASLD, Type 2 Diabetes

In brief

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 facts

Study ID

NCT06701968

Run by

Uppsala University

People needed

150

Starts

2025-03-20

Expected to finish

2031-12-30

Last updated by the study team

2025-03-06

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Cardiology clinic, Uppsala university hospital — Uppsala, Sweden (enrolling)

Full record on ClinicalTrials.gov

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