Effect of a vegetarian diet on innate immunity in patients with myocardial infarction and in healthy volunteers (FRESH-MI study)
- Conditions
- heart attackmyocardial infarction1001108210003216
- Registration Number
- NL-OMON53267
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion criteria for patients:
- Age >= 18 years
- Acute myocardial infarction (STEMI/NSTEMI) with a clear culprit lesion on
angiography and requiring primary PCI less than 1 week before randomisation
- Body mass index between 18.5 and 35 kg/m2
- Written informed consent
Inclusion criteria for healthy volunteers (life partners / spouses)
- Age >= 18 years
- Body mass index between 20 and 35 kg/m2
- Written informed consent
Exclusion criteria for patients and healthy volunteers (life partners/spouses):
- Already on a vegetarian 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 (e.g., NSAID, Prednisone)
- Vaccination less than one month before inclusion
- Clinically significant infections within 1 months prior to study entry
(defined as fever >=38.5 degrees Celcius)
- Active malignant haematological disease
- Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)
Exclusion criteria only for healthy volunteers (life partners / spouses):
- Use of lipid lowering therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in cytokine production capacity of isolated peripheral blood<br /><br>mononuclear cells after ex-vivo stimulation before and after the vegetarian<br /><br>diet in group 2a AMI compared to the difference in cytokine production capacity<br /><br>before and after the no change diet in group 2b AMI.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The cytokine production capacity of isolated peripheral blood mononuclear<br /><br>cells after ex-vivo stimulation before and after following a vegetarian diet in<br /><br>healthy participants (delta group 1 PAR and delta group 2 PAR).<br /><br>- The cytokine production capacity of isolated peripheral blood mononuclear<br /><br>cells after ex-vivo stimulation after following a vegetarian diet compared to a<br /><br>no change diet in patients with a recent myocardial infarction (group 1 AMI<br /><br>versus group 2 AMI.<br /><br>- The frequency of the consumption of vegetables per week at nine months<br /><br>follow-up.<br /><br>- Systemic markers of inflammation (cytokines and chemokines)<br /><br>- Leucocyte composition<br /><br>- Phenotype of circulating monocytes on flow cytometry<br /><br>- Lipid profile</p><br>