Actively Recruiting
Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease
Led by Uppsala University · Updated on 2025-03-06
150
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
F
Falu Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Diagnosed with myocardial infarction from 2 weeks to 6 months after diagnosis
- Diagnosed with chronic coronary syndrome (e.g., stable angina pectoris)
- Aged 50 to 80 years
- Body Mass Index (BMI) between 25 and 40
You will not qualify if you...
- Severe heart failure classified as NYHA classes III or IV
- Alcohol intake greater than 20 grams per day
- Unwillingness to follow a new prescribed diet for 18 months
- Other diseases with short estimated life expectancy (e.g., severe malignant, kidney, or liver disease, as judged by physician)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiology clinic, Uppsala university hospital
Uppsala, Sweden
Actively Recruiting
Research Team
E
Emil Hagström, MD, PHD
CONTACT
F
Fredrik Rosqvist, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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