About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Healthy Nordic Diet
Other interventionParticipants will be adviced a healthy Nordic diet and will also receive certain Nordic foods high in wholegrains and polyunsaturated fat from vegetable sources
Usual Care
BehavioralUsual care lifestyle advice and national and general recommendations on diet
Treatment groups
Trial outcomes
Primary outcomes
Change in coronary plaque volume
Will be assessed by photon-counting CT angiography
Secondary outcomes
Change in coronary inflammation: Fat attenuation Index
Perivascular fat will be assessed by photon counting CT angiography
To investigate if a Healthy Nordic Diet can decrease progression of atherosclerosis Change in coronary artery calcium score (CACS)
CACS will be assessed by photon counting CT angiography
Change in ectopic fat (liver, heart, muscle)
Will be assessed by photon counting CT angiography
Change in blood glycemic control
Will be measured in fasting state and continously using CGM
Other outcomes
Change in gut microbiota
Gut microbiota will be measured in fecal samples
Change in plasma inflammation proteins
Protemomic approcah will be used
Change in plasma lipidomic profile including ceramides
Lipidomic approach will be used
Change in plasma metabolite pattern
A metabolomic approach will be used
Sponsors and contacts
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Uppsala University
Lead sponsor
Falu Hospital
Collaborator