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Recruiting Not applicable

Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)

NCT06209723 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2024-01-26
Last updated
2026-08-14

Condition(s) studied

Myocardial Infarction

Investigational drug(s) / intervention(s)

Vegetarian diet

Vegetarian diet: Participants will follow a vegetarian diet during a period of five weeks

Study summary

The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria for patients: * Acute myocardial infarction (STEMI/NSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \<1 week before randomisation * Body mass index between 18.5 and 35 kg/m2 * Written informed consent Inclusion Criteria for healthy volunteers (life partners / souses) * Body mass index between 18.5 and 35 kg/m2 * Written informed consent Exclusion Criteria for patients and healthy volunteers: * Already on a vegetarian or vegan diet * Previous myocardial infarction * Diabetes Mellitus * Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant) * Use of immunomodulatory drugs * Vaccination less than one month before start of intervention * Clinically significant infections within 1 months prior to start of intervention (defined as fever \>38.5 degrees Celsius) * Active malignant haematological disease * Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa) Exclusion Criteria for healthy volunteers \- Use of lipid lowering therapy

Primary outcome measure(s)

  • The difference in cytokine production capacity (including TNF-α, IL-6, IL-10, IL-1β) of isolated peripheral blood mononuclear cells (PBMCs) after ex-vivo stimulation before and after the vegetarian diet compared to the habitual diet in patients with AMI — five weeks

Trial sites (1)

FacilityCityRegionStatus
Radboudumc Nijmegen Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06209723 on ClinicalTrials.gov ↗ ← All trials in the Netherlands