acute coronary syndrome
Conditions
Interventions
Study subjects will be randomly assigned to a vegetarian or their habitual
(meat-rich) diet for five weeks. Then a stabilisation period of six weeks will
follow. After that participants will follow
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Exclusion criteria for patients and healthy volunteers (life partners/spouses): - Already on a vegetarian diet - Previous myocardial infarction in the past 1 year prior to index event - 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - The cytokine production capacity of isolated peripheral blood mononuclear cells after ex-vivo stimulation before and after following a vegetarian diet in healthy participants (delta group 1 PAR and delta group 2 PAR). - The cytokine production capacity of isolated peripheral blood mononuclear cells after ex-vivo stimulation after following a vegetarian diet compared to a no change diet in patients with a recent myocardial infarction (group 1 AMI versus group 2 AMI. - The frequency of the consumption of vegetables per week at nine months follow-up. - Systemic markers of inflammation (cytokines and chemokines) - Leucocyte composition - Phenotype of circulating monocytes on flow cytometry - Lipid profile | — |
Primary
| Measure | Time frame |
|---|---|
| The difference in cytokine production capacity of isolated peripheral blood mononuclear cells after ex-vivo stimulation before and after the vegetarian diet in group 2a AMI compared to the difference in cytokine production capacity before and after the no change diet in group 2b AMI. | — |
Countries
Netherlands
Contacts
Public ContactB Yosofi
Radboud Universitair Medisch Centrum
Outcome results
None listed