Actively Recruiting
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
Eligibility Criteria
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)
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
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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