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

Sponsor
Radboud University Medical Center
Study ID
NCT06209723
Status
Recruiting
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Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vegetarian diet — OTHER
    Participants will follow a vegetarian diet during a period of five weeks

Study Details

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.

Key Dates

First listed
Jan 17, 2024
Start date
Jan 8, 2024
Status verified
Jan 2024
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome 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 [ Time Frame: five weeks ]

Central Contacts

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