Actively Recruiting
A Healthy Nordic Diet to Reduce the Progression of Atherosclerosis in Individuals with Coronary Heart Disease: a Secondary Prevention Trial
Led by Uppsala University · Updated on 2025-03-06
150
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
F
Falu Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how a healthy Nordic diet (HND) may affect atherosclerosis and coronary heart disease (CHD). This trial focuses on whether the HND can reduce plaque volume, coronary artery calcification, and plaque inflammation in people with CHD. The study also explores if changes in gut microbiota relate to plaque progression and whether individual metabolic profiles can predict diet responses. This randomized, double-blinded trial includes 150 patients with a history of myocardial infarction or chronic coronary syndrome, aged 50 to 80 years. Participants are assigned to one of two groups: one receives dietary advice plus key Nordic foods rich in whole grains and unsaturated fats, while the other receives usual care dietary advice as per national guidelines. The intervention lasts 18 months, with dietary intake monitored through food records and biomarkers at multiple points. Coronary plaque and composition are assessed using advanced CT angiography at the start and end of the study. Blood glucose and heart activity are tracked using wearable monitors. Throughout the study, researchers will evaluate changes in coronary plaque volume as the primary outcome, along with plaque composition, inflammation, coronary artery calcium, ectopic fat, blood lipids, blood pressure, and cardiovascular events. They will also analyze gut microbiota and metabolic profiles to identify responders to the diet. Follow-up includes monitoring these markers up to 30 months. This comprehensive approach aims to provide new insights into diet's role in managing coronary artery disease.
CONDITIONS
Brief 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 up to 6 months after diagnosis
- Diagnosed with chronic coronary syndrome, such as stable angina pectoris
- Aged between 50 and 80 years
- Body mass index (BMI) between 25 and 40
You will not qualify if you...
- Severe heart failure classified as NYHA class III or IV
- Alcohol intake greater than 20 grams per day
- Unwillingness to follow a new prescribed diet for 18 months
- Other serious diseases with short life expectancy, such as severe cancer, kidney, or liver disease as judged by a physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants follow either a Healthy Nordic Diet or usual care dietary advice to influence coronary plaque volume and cardiovascular risk.
Visits at baseline, 6 months, 12 months, and 18 months to monitor diet and health markers
Duration - 12 months
Participants are monitored for cardiovascular events and long-term effects up to 12 months after the treatment period ends.
1 visit at 30 months after study entry
Trial Site Locations
Total: 1 location
1
Cardiology clinic, Uppsala university hospital
Uppsala, Sweden
Actively Recruiting
Research Team
E
Emil Hagström, MD, PHD
F
Fredrik Rosqvist, PHD
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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