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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Body mass index between 18.5 and 35 kg/m2

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vegetarian diet

    Other intervention

    Participants will follow a vegetarian diet during a period of five weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Vegetarian dietExperimental treatment 1 intervention
Group B: No change dietNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
five weeks

Secondary outcomes

1

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.

Time frame
five weeks
2

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.

Time frame
9 months

Other outcomes

Sponsors and contacts

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