A Healthy Nordic Diet to Reduce the Progression of Atherosclerosis in Individuals with Coronary Heart Disease: a Secondary Prevention Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Cardiology clinic, Uppsala university hospital
RECRUITING
Uppsala
Contact Information
Primary
Emil Hagström, MD, PHD
emil.hagstrom@ucr.uu.se
46184710000
Backup
Fredrik Rosqvist, PHD
fredrik.rosqvist@uu.se
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2031-12-30
Participants
Target number of participants: 150
Treatments
Experimental: Healthy Nordic Diet
Dietary advice and provided with some key food items of the healthy Nordic diet
Active_comparator: Usual care
Dietary advice according to standard clinical care at the cardiology unit
Sponsors
Leads: Uppsala University
Collaborators: Falu Hospital

This content was sourced from clinicaltrials.gov