Time Restricted Eating and Innate Immunity

NCT05639244 | Completed

• 1 other identifier: NL80950.091.22
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Time Restricted Feeding; Myocardial Infarction; Atherosclerotic Cardiovascular Disease

Keywords

time restricted eating

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Time restricted eating (TRE); Behavioral: Regular diet

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.

Behavioral: Time restricted eating (TRE); Behavioral: Regular diet

Interventions

Time restricted eating (TRE) BEHAVIORAL

Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.

First TRE, then regular diet; First regular diet, then TRE

Regular diet BEHAVIORAL

Participants have to consume their regular diet within an unrestricted time period for 2 weeks

First TRE, then regular diet; First regular diet, then TRE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Heart Foundation: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 GB, Netherlands

Location

MeSH Terms

Conditions

Intermittent Fasting; Myocardial Infarction; Atherosclerosis

Interventions

Diet

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Niels P. Riksen, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: December 6, 2022
• Study Start: November 17, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data from the research project will be shared after the publication of the results.
• Access Criteria: All data will be made available without restrictions.

Locations

NL (1)