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

Myocardial Infarction Clinical Trial

— FRESH-MI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209723
• Other study ID #: NL84172.091.23
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: Robin Nijveldt, MD, PhD
• Phone: 0031243616785
• Email: robin.nijveldt[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Vegetarian diet
Participants will follow a vegetarian diet during a period of five weeks

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in cytokine production capacity (including TNF-a, IL-6, IL-10, IL-1ß) 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		five weeks
Secondary	The cytokine production capacity (including TNF-a, IL-6, IL-10, IL-1ß) of isolated peripheral blood mononuclear cells after ex-vivo stimulation before and after following a vegetarian diet in participants without cardiovascular history.		five weeks
Secondary	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.		9 months