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

NCT06209723 | Recruiting

• 1 other identifier: NL84172.091.23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

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

  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.

  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.

  9 months

Study Arms (2)

Vegetarian diet

EXPERIMENTAL

Vegetarian diet during five weeks

Other: Vegetarian diet

No change diet

NO INTERVENTION

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

Interventions

Vegetarian diet OTHER

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

Vegetarian diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Diet, Vegetarian

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robin Nijveldt, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Saloua El Messaoudi, MD, PhD

  Radboud University Medical Center

  STUDY CHAIR

Central Study Contacts

Robin Nijveldt, MD, PhD

CONTACT

0031243616785; robin.nijveldt@radboudumc.nl

Saloua El Messaoudi, MD, PhD

CONTACT

0031243616785; Saloua.ElMessaoudi@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: January 17, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

NL (1)