Effect of a vegetarian diet on immunity in heart attack patients and healthy volunteers
Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
This study is testing whether a vegetarian diet can improve immunity in people who have had a heart attack and their healthy partners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT06209723 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced an acute myocardial infarction within the past week and have a body mass index between 18.5 and 35.
Not a fit: Patients with a history of diabetes, previous myocardial infarction, or those on immunomodulatory drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that enhance immune function and recovery in heart attack patients.
How similar studies have performed: While dietary interventions have been explored in various contexts, this specific approach focusing on vegetarian diets in myocardial infarction patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa) Exclusion Criteria for healthy volunteers \- Use of lipid lowering therapy
Where this trial is running
Nijmegen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.