Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06209723

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

Led by Radboud University Medical Center · Updated on 2024-01-17

120

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute myocardial infarction (STEMI or NSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention within 1 week before randomization (for patients)
  • Body mass index between 18.5 and 35 kg/m2
  • Written informed consent
  • Body mass index between 18.5 and 35 kg/m2 (for healthy volunteers/life partners/spouses)
  • Written informed consent (for healthy volunteers/life partners/spouses)
Not Eligible

You will not qualify if you...

  • Already following a vegetarian or vegan diet
  • Previous myocardial infarction
  • Diabetes Mellitus
  • History of any disease causing immune deficiency, including chemotherapy, chronic steroid use, or organ transplant
  • Use of immunomodulatory drugs
  • Vaccination less than one month before starting the intervention
  • Clinically significant infections within one month prior to starting the intervention (fever over 38.5 degrees Celsius)
  • Active malignant hematological disease
  • Known eating disorders such as anorexia nervosa or bulimia nervosa
  • Use of lipid lowering therapy (for healthy volunteers)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Radboudumc

Nijmegen, Netherlands

Actively Recruiting

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Research Team

R

Robin Nijveldt, MD, PhD

CONTACT

S

Saloua El Messaoudi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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