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Recruiting NCT06209723

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

Trial Parameters

Condition Myocardial Infarction
Sponsor Radboud University Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-08
Completion 2026-09-01
Interventions
Vegetarian diet

Brief 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 Criteria

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 * K

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