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Completed

NCT Number: NCT05639244

Time Restricted Eating and Innate Immunity

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.

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Key information

Conditions

Time Restricted Feeding Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Behavior Cardiovascular Diseases Fasting Feeding Behavior Heart Diseases Infarction Intermittent Fasting Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, Gelderland, 6500 GB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

time restricted eating (TRE)

Behavioral

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

Regular diet

Behavioral

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

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.

    Time frame: Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet.

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Official study title

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

Acronym: SIGNATURE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2022
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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