NCT06701968 Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease
| NCT ID | NCT06701968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Coronary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-03-20 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Ulf Risérus, MMED, PHD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT06701968 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06701968 currently recruiting?
Yes, NCT06701968 is actively recruiting participants. Contact the research team at emil.hagstrom@ucr.uu.se for enrollment information.
Where is the NCT06701968 trial being conducted?
This trial is being conducted at Uppsala, Sweden.
Who is sponsoring the NCT06701968 clinical trial?
NCT06701968 is sponsored by Uppsala University. The principal investigator is Ulf Risérus, MMED, PHD at Uppsala University. The trial plans to enroll 150 participants.