To determine the effect of a five-week vegetarian diet on innate immunity of patients with a recent myocardial infarction and healthy participants.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- 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
Background summary
Inflammation plays a pivotal role in the development of atherosclerosis. Recent
evidence suggests that plant-based diets may have favourable effects on
inflammation. Inflammatory parameters such as total leucocytes, neutrophils and
monocytes significantly reduce after starting a vegetarian diet. Also, plant
based diet reduces the number of circulating monocytes. Based on these
findings, we hypothesize that a vegetarian diet, compared to a habitual
meat-rich diet, reduces the pro-inflammatory monocyte phenotype in patients
with a recent myocardial infarction. If our hypothesis is proven, this provides
alternative non-pharmacological therapeutical options in this high risk
population.
Study objective
To determine the effect of a five-week vegetarian diet on innate immunity of
patients with a recent myocardial infarction and healthy participants.
Study design
Prospective randomized open label blinded endpoint (PROBE) study.
Intervention
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 the other dietary intervention for
five weeks. A part of the participants will then start directly with the other
dietary intervention and a part will start after five weeks. Blood will be
drawn at given timepoints The frequency and time points at which blood samples
will be taken, are different for each group. See figure 1 of the protocol. At
baseline, at 12 weeks and at 9 months follow-up questionnaires will be taken.
Study burden and risks
There are no significant risks to subjects included in this dietary
intervention study. Blood will be drawn during study visits, which will have
negligible risk. Subjects might benefit because the intervention could have a
positive impact on the primary and secondary prevention of myocardial
infarction.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
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 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84172.091.23 |