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Time Restricted Eating and Innate Immunity (SIGNATURE)

Primary Purpose

Time Restricted Feeding, Myocardial Infarction, Atherosclerotic Cardiovascular Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Time restricted eating (TRE)
Regular diet
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Time Restricted Feeding focused on measuring time restricted eating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud university medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

First TRE, then regular diet

First regular diet, then TRE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2022
Last Updated
December 5, 2022
Sponsor
Radboud University Medical Center
Collaborators
Dutch Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05639244
Brief Title
Time Restricted Eating and Innate Immunity
Acronym
SIGNATURE
Official Title
Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time Restricted Feeding, Myocardial Infarction, Atherosclerotic Cardiovascular Disease
Keywords
time restricted eating

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First TRE, then regular diet
Arm Type
Other
Arm Description
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.
Arm Title
First regular diet, then TRE
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating (TRE)
Intervention Description
Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Regular diet
Intervention Description
Participants have to consume their regular diet within an unrestricted time period for 2 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niels. P. Riksen, Prof. Dr.
Phone
024-3698385
Email
Niels.Riksen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Wieteke Broeders, MD
Phone
024-3667210
Email
Wieteke.broeders@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels P. Riksen, Prof. Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 GB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels P. Riksen, MD, PhD
Phone
0031-24-3618819
Email
niels.riksen@radboudumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Time Restricted Eating and Innate Immunity

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