Effects of a Healthy Nordic Diet on Atherosclerosis in Patients with Coronary Heart Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUppsala University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Healthy Nordic Diet

    Other intervention

    Participants 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

    Behavioral

    Usual care lifestyle advice and national and general recommendations on diet

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Healthy Nordic DietExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in coronary plaque volume

Will be assessed by photon-counting CT angiography

Time frame
18 months

Secondary outcomes

1

Change in coronary inflammation: Fat attenuation Index

Perivascular fat will be assessed by photon counting CT angiography

Time frame
18 months
2

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

Time frame
18 months
3

Change in ectopic fat (liver, heart, muscle)

Will be assessed by photon counting CT angiography

Time frame
18 months
4

Change in blood glycemic control

Will be measured in fasting state and continously using CGM

Time frame
6, 12 and 18 months

Other outcomes

1

Change in gut microbiota

Gut microbiota will be measured in fecal samples

Time frame
12 and 18 months
2

Change in plasma inflammation proteins

Protemomic approcah will be used

Time frame
6, 12 and 18 months
3

Change in plasma lipidomic profile including ceramides

Lipidomic approach will be used

Time frame
6, 12 and 18 months
4

Change in plasma metabolite pattern

A metabolomic approach will be used

Time frame
6, 12 and 18months

Sponsors and contacts

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Uppsala University

Lead sponsor

Falu Hospital

Collaborator