Time Restricted Eating and Innate Immunity

Myocardial Infarction Clinical Trial

— SIGNATURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05639244
• Other study ID #: NL80950.091.22
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Time Restricted Feeding

Intervention

Behavioral:
• Time restricted eating (TRE)
Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.
• Regular diet
Participants have to consume their regular diet within an unrestricted time period for 2 weeks

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.