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

R

Radboud University Medical Center

Status

Enrolling

Conditions

Myocardial Infarction

Treatments

Other: Vegetarian diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06209723
NL84172.091.23

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Vegetarian diet
Experimental group
Description:
Vegetarian diet during five weeks
Treatment:
Other: Vegetarian diet
No change diet
No Intervention group
Description:
The 'habitual' diet during five weeks. There are no specific restrictions to their diet.

Trial contacts and locations

1

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Central trial contact

Saloua El Messaoudi, MD, PhD; Robin Nijveldt, MD, PhD

Data sourced from clinicaltrials.gov

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