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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First TRE, then regular diet | Other | 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. |
|
| First regular diet, then TRE | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating (TRE) | Behavioral | Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels P. Riksen, Prof. Dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Gelderland | 6500 GB | Netherlands |
Data will be published in a data repository or other online data archive (e.g. DANS EASY, Radboud Data Repository, disciplinary repository, data archive). Data that is applicable for sharing (regarding privacy) will be published.
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All data from the research project will be shared after the publication of the results.
All data will be made available without restrictions.
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D009203 | Myocardial Infarction |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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| Regular diet | Behavioral | Participants have to consume their regular diet within an unrestricted time period for 2 weeks |
|
| D006331 |
| Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |