Coronary artery disease
Conditions
Interventions
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
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cytokine production capacity of isolated peripheral blood mononuclear cells (PBMCs) after ex-vivo stimulation with relevant stimuli. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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.. | — |
Countries
Netherlands
Outcome results
None listed