Time Restricted Eating and Innate Immunity (SIGNATURE)

Radboud University Medical Center

Status: Completed

Conditions: Atherosclerotic Cardiovascular Disease; Time Restricted Feeding; Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05639244

NL80950.091.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

First TRE, then regular diet

Other group

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.

Treatment:

Behavioral: Time restricted eating (TRE)

Behavioral: Regular diet

First regular diet, then TRE

Other group

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.

Treatment:

Behavioral: Time restricted eating (TRE)

Behavioral: Regular diet