Time Restricted Eating and Innate Immunity (SIGNATURE)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Time Restricted Feeding
• Intervention / Treatment: Behavioral: Time restricted eating (TRE); Behavioral: Regular diet

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niels. P. Riksen, Prof. Dr.; Phone Number: 024-3698385; Email: Niels.Riksen@radboudumc.nl
• Study Contact Backup: Name: Wieteke Broeders, MD; Phone Number: 024-3667210; Email: Wieteke.broeders@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 GB
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: First TRE, then regular diet; 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); Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.; Behavioral: Regular diet; Participants have to consume their regular diet within an unrestricted time period for 2 weeks
Other: First regular diet, then TRE; 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); Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.; Behavioral: Regular diet; Participants have to consume their regular diet within an unrestricted time period for 2 weeks

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Dutch Heart Foundation
• Investigators: Principal Investigator: Niels P. Riksen, Prof. Dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: time restricted eating
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: NL80950.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: All data from the research project will be shared after the publication of the results.
• IPD Sharing Access Criteria: All data will be made available without restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No