Time Restricted Eating and Innate Immunity

Study Overview
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Brief Summary
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The goal of this cross over study is to investigate the effect of short term time restricted eating (TRE) on the innate immune system in patients with a history of myocardial infarction.

Detailed Description
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In the recent years, research has shown the prominent role of low grade systemic inflammation in cardiovascular disease (CVD) and the crucial role myeloid cells, mainly monocytes and macrophages, play in atherogenesis. 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 reduces the number of circulating monocytes. It is now hypothesized that TRE reduces the pro-inflammatory monocyte phenotype of patients with a history of myocardial infarction. Therefore, the investigators will perform a exploratory prospective randomised open label blinded endpoint cross-over study to investigate the effect of short term TRE on the innate immune system in patients with a history of myocardial infarction.

Official Title
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Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease

Conditions
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Time Restricted Feeding, Myocardial Infarction, Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Time restricted eating (TRE)
* Behavioral: Regular diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age >18 years) Diagnosed with a myocardial infarction (between 1 and 5 years ago) 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), coronary artery bypass graft surgery or other major (cardiovascular) surgery, stroke or transient ischemic attack (TIA) in the past 1 year prior to screening. Use of immunomodulatory drugs Use of drugs that need to be taken with food. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The investigators will include 20 adult patients. Participants will be randomised to a 2 week time restricted eating (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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First TRE, then regular diet<br>This group will start with 2 weeks TRE and will switch to the 2 week period of consuming their regular diet after a wash-out period. | Behavioral: Time restricted eating (TRE)<br>* Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.<br>Behavioral: Regular diet<br>* Participants have to consume their regular diet within an unrestricted time period for 2 weeks<br>|
| Other: First regular diet, then TRE<br>This group will start with the 2 week period of consuming their regular diet and will switch to 2 weeks TRE after a wash-out period. | Behavioral: Time restricted eating (TRE)<br>* Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.<br>Behavioral: Regular diet<br>* Participants have to consume their regular diet within an unrestricted time period for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the inflammatory phenotype of circulating immune cells, assessed by measuring the cytokine production capacity (e.g. IL-1b and TNF) of isolated PBMCs after ex vivo stimulation with various TLR ligands, determined by ELISA. | The investigators will measure the change in the inflammatory phenotype of circulating immune cells after TRE. Therefore, the investigators will assess the inflammatory phenotype at baseline and after a two week TRE period and a control period with a regular diet (cross-over design). This will be assessed by measuring the cytokine production capacity of isolated peripheral blood mononuclear cells (PBMCs) after ex vivo stimulation with various TLR ligands. Relevant cytokines (e.g. IL-1b and TNF, given in pg/ml) are measured in the supernatants of the PMBC stimulation experiments by ELISA. | Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time restricted eating