Myocardial InfarctionFRESH-MINCT06209723
Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
A study testing Vegetarian diet in people with Myocardial Infarction, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Vegetarian diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jan 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
- Use of lipid lowering therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Robin Nijveldt, MD
About this study
Official title: Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
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.
Read the detailed 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.
- Conditions
- Myocardial Infarction
- Being tested
- Vegetarian diet
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian dietOther
Participants will follow a vegetarian diet during a period of five weeks
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian diet | Experimental | Vegetarian diet during five weeks Receives: Other: Vegetarian diet |
| No change diet | No intervention | The 'habitual' diet during five weeks. There are no specific restrictions to their diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: five weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start26 Jan 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Nijveldt, Radboud University Medical Center
- Investigators
- Robin Nijveldt, MD, PhD, Principal investigator, Radboud University Medical CenterSaloua El Messaoudi, MD, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209723
- Sponsor's protocol ID
- NL84172.091.23
- Acronym
- FRESH-MI
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
- ClinicalTrials.gov ID
- NCT06209723
- Acronym / sponsor ID
- FRESH-MI / NL84172.091.23
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetarian diet | Experimental | Other: Vegetarian dietVegetarian diet during five weeks |
| No change diet | No intervention | –The 'habitual' diet during five weeks. There are no specific restrictions to their diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetarian dietParticipants will follow a vegetarian diet during a period of five weeks | Other | Vegetarian diet |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Nijveldt, MD, PhD principal investigator
Radboud University Medical Center
Saloua El Messaoudi, MD, PhD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetarian diet in people with Myocardial Infarction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Nijveldt, MD, PhD (0031243616785, robin.nijveldt@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.