An interventional study of Vegetarian diet in Myocardial Infarction, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 120 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
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Inclusion Criteria for healthy volunteers (life partners / souses)
Exclusion Criteria for patients and healthy volunteers:
Exclusion Criteria for healthy volunteers
- Use of lipid lowering therapy
Vegetarian diet during five weeks
Other: Vegetarian diet
The 'habitual' diet during five weeks. There are no specific restrictions to their diet.
Participants will follow a vegetarian diet during a period of five weeks
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
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
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
Plan to share: Yes — No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Radboud University Medical Center