Clinical trial NCT05639244: Time Restricted Eating and Innate Immunity
Official title: Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Myocardial Infarction
Atherosclerotic Cardiovascular Disease
Keywords: time restricted eating
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2022-12-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet.
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Niels P. Riksen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: