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

NCT ID: NCT06209723

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-09-01

Brief 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. 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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vegetarian diet

Vegetarian diet during five weeks

Group Type: EXPERIMENTAL

Vegetarian diet

Intervention Type: OTHER

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

No change diet

The 'habitual' diet during five weeks. There are no specific restrictions to their diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vegetarian diet

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Written informed consent

Exclusion Criteria

• 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)

• Use of lipid lowering therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robin Nijveldt

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Nijveldt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Saloua El Messaoudi, MD, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Robin Nijveldt, MD, PhD

Role: CONTACT

robin.nijveldt@radboudumc.nl

0031243616785

Saloua El Messaoudi, MD, PhD

Role: CONTACT

Saloua.ElMessaoudi@radboudumc.nl

0031243616785

Facility Contacts

Robin Nijveldt, MD

Role: primary

Other Identifiers

NL84172.091.23

Identifier Type: -

Identifier Source: org_study_id