NCT06701968Recruiting
Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease
A Healthy Nordic Diet to Reduce the Progression of Atherosclerosis in Individuals with Coronary Heart Disease: a Secondary Prevention Trial
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 20 Mar 2025
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Uppsala University
- NCT number
- NCT06701968
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 20 Mar 2025 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe heart failure (NYHA classes III, IV)
- Other diseases implying a short estimated life expectancy (e.g. severe malignant or kidney or liver disease, as judged by consenting physician).
Other
- Alcohol intake \>20g/day
- Unwillingness to follow a new prescribed diet for 18 months
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology clinic, Uppsala university hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.