Effect of a vegetarian diet on immunity in heart attack patients and healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate how a vegetarian diet influences innate immunity in patients who have recently experienced a myocardial infarction and their healthy partners. Participants will be randomly assigned to either a vegetarian diet or their usual diet for five weeks, followed by a six-week stabilization period. Blood samples will be collected at various time points to analyze inflammatory markers, and participants will complete questionnaires to assess dietary adherence and willingness to maintain a vegetarian lifestyle. The study employs a prospective randomized open label blinded endpoint (PROBE) design to ensure robust results.

Why it matters

Who can join: the full rules

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

Where it's running

• Radboudumc
  Nijmegen, Netherlands Recruiting

Study contacts

• Principal investigator: Robin Nijveldt, MD, PhD — Radboud University Medical Center
• Study coordinator: Robin Nijveldt, MD, PhD
• Email: robin.nijveldt@radboudumc.nl
• Phone: 0031243616785

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.