Clinical trial NCT06209723: Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
Official title: Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: We will perform a proof-of-concept study according to a prospective randomized open label blinded endpoint (PROBE) design. Patients with an acute myocardial infarction (AMI) and their healthy life partners / spouses will be randomly assigned to an immediate vegetarian diet or their habitual diet. Patients with AMI will be stratified for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI). The dietary intervention will start one week after the index event and will comprise a period of five weeks. After a stabilisation phase (six weeks), to assure normalisation of the inflammatory response secondary to the acute myocardial infarction, patients and their spouses will follow the other dietary intervention arm. Then, half of them will start directly with the other dietary intervention and half of them will start after a period of five weeks. Blood samples will be taken at the time points. Also, all participants will be asked to complete a questionnaire at baseline, after twelve weeks and at nine months follow-up. Infarct size as assessed by Cardiovascular Magnetic Resonance (CMR) imaging will be used to adjust cytokine levels.

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
* Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)

Exclusion Criteria for healthy volunteers

- Use of lipid lowering therapy

Primary outcomes:
measure: 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
timeFrame: five weeks
Secondary outcomes:
measure: The cytokine production capacity (including TNF-α, IL-6, IL-10, IL-1β) of isolated peripheral blood mononuclear cells after ex-vivo stimulation before and after following a vegetarian diet in participants without cardiovascular history.
timeFrame: five weeks
measure: The frequency of the consumption of vegetables per week at nine months follow-up will be compared between patients with a recent acute myocardial infarction, who directly start with a vegetarian diet compared to a deferred start.
timeFrame: 9 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Robin Nijveldt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Saloua El Messaoudi, MD, PhD
role: STUDY_CHAIR
References: