RecruitingNot ApplicableNCT06209723

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

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

Sponsor

Radboud University Medical Center

Enrollment

120 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Myocardial Infarction

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

Min Age: 18 Years

Inclusion Criteria5

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
Body mass index between 18.5 and 35 kg/m2
Written informed consent

Exclusion Criteria10

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)
\- Use of lipid lowering therapy