To investigate the effect of short term TRE on the innate immune system in patients with a history of myocardial infarction.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Cytokine production capacity of isolated peripheral blood mononuclear cells
(PBMCs) after ex-vivo stimulation with relevant stimuli.
Secondary outcome
- Immune cell composition
- Circulating inflammatory markers
- Circulating metabolites
- Clinical cardiovascular risk factors: body weight, blood pressure, heart
rate, BMI
- Cardiovascular risk factors in the blood:
o before start: renal function (creatinine), glucose, cholesterol (total,
HDL-c, LDL-c, triglycerides), and lipoprotein(a), and uric acid measured via
venous blood analysis
o Before and after the two diet interventions, we will measure glucose and
cholesterol values.
- In a selection of subjects we will perform RNAsequencing and chromatin
immunoprecipition to detect histone modifications.
- We will store plasma and serum in -80 C..
Background summary
Atherosclerotic cardiovascular diseases (CVD) are an important cause of
morbidity and mortality. In the recent years, research has shown the prominent
role of low grade systemic inflammation in CVD and the crucial role myeloid
cells, mainly monocytes and macrophages, play in atherogenesis. The current
treatment of atherosclerotic CVD is based on lifestyle changes and
pharmacological treatment. However, many optimally treated patients remain
suffering from recurrent events, which seems to be primarily driven by
inflammation.
Lifestyle and diet interventions have become more important in the treatment
and prevention of CVD. Time restricted eating (TRE), i.e. eating the normal
amount of calories within a limited time period per day, has a beneficial
effect on multiple factors involved in the development of CVD, such as blood
pressure, heart rate, lipid and blood glucose levels, and insulin sensitivity.
TRE also reduces markers of systemic inflammation and oxidative stress; markers
that are involved in atherogenesis. Besides, short term TRE reduces the number
of circulating monocytes.
Based on these findings, we hypothesize that TRE reduces the pro-inflammatory
monocyte phenotype of patients with a history of myocardial infarction. Proof
of this hypothesis will have clinical implications and helps creating more
treatment options for patients with CVD.
Study objective
To investigate the effect of short term TRE on the innate immune system in
patients with a history of myocardial infarction.
Study design
Exploratory prospective randomised open label blinded endpoint (PROBE) cross
over study.
Participants will be randomised to a 2 week TRF period or a 2 week period in
which they consume their regular diet within an unrestricted time period.
Participants will be crossed over to the other treatment arm after a 6 weeks
wash-out period. In the TRF-arm, participants have to consume their regular
food intake during a 6 hour period (from 8:00 to 14:00), after which they start
fasting for 18 hours. Blood will be drawn before and on the last day of both
diet intervention periods
Intervention
Participants will be randomised to a 2 week TRE period or a 2 week period in
which they consume their regular diet within an unrestricted time period.
Participants will be crossed over to the other treatment arm after a 6 weeks
wash-out period. In the TRE-arm, participants have to consume their regular
food intake during a 6 hour period (from 8:00 to 14:00), after which they start
fasting for 18 hours. During this fasting period, the participants are only
allowed to drink water. They will be helped by a dietician.
Blood will be drawn before and on the last day of both diet intervention
periods.
Study burden and risks
There will be no risk. The participation will only include venous blood drawing
and a diet intervention.
The burden associated with participation:
- Subjects must adhere to fixed times of eating and fasting.
- Test subjects may be bothered by the measurements during the study. For
example, taking a blood sample may cause some pain or bruising.
- Participating in the study will cost extra time.
Geert Grooteplein Zuid 10
Nijmegen 6225 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6225 GA
NL
Listed location countries
Age
Inclusion criteria
- Adult (age >18 years)
- Diagnosed with a myocardial infarction (1 to 5 years ago diagnosed)
- Body mass index between 20 and 35 kg/m2
- Able to understand, be motivated and follow the study related procedures
- Able to understand and give written informed consent
Exclusion criteria
- Myocardial infarction (defined as an increase in cardiac enzymes in
combination with symptoms of ischemia or newly developed ischemic ECG changes)
in the year prior to screening.
- Coronary artery bypass graft surgery or other major (cardiovascular) surgery,
stroke or transient ischemic attack (TIA) in the past 6 months days prior to
screening.
- Use of immunomodulatory drugs
- Diabetes Mellitus type I and type II
- Medical history of any disease associated with immune deficiency (either
congenital or acquired, including chemotherapy, active malignancy, organ
transplant) or auto immune disease
- Clinically significant infections within 1 months prior to start of or
during intervention period or control period (defined as fever >38.5).
- Vaccination <1 month before start of or during intervention or control
period.
- Eating disorders
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 | NL80950.091.22 |