Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT06701968

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

Led by Uppsala University · Updated on 2025-03-06

150

Participants Needed

1

Research Sites

353 weeks

Total Duration

On this page

Sponsors

U

Uppsala University

Lead Sponsor

F

Falu Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Diagnosed with myocardial infarction from 2 weeks to 6 months after diagnosis
  • Diagnosed with chronic coronary syndrome (e.g., stable angina pectoris)
  • Aged 50 to 80 years
  • Body Mass Index (BMI) between 25 and 40
Not Eligible

You will not qualify if you...

  • Severe heart failure classified as NYHA classes III or IV
  • Alcohol intake greater than 20 grams per day
  • Unwillingness to follow a new prescribed diet for 18 months
  • Other diseases with short estimated life expectancy (e.g., severe malignant, kidney, or liver disease, as judged by physician)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cardiology clinic, Uppsala university hospital

Uppsala, Sweden

Actively Recruiting

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Research Team

E

Emil Hagström, MD, PHD

CONTACT

F

Fredrik Rosqvist, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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