Time Restricted Eating and Innate Immunity

NCT ID: NCT05639244

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2024-01-25

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.

Conditions

Time Restricted Feeding; Myocardial Infarction; Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Time restricted eating (TRE)

Intervention Type: BEHAVIORAL

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

Regular diet

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Time restricted eating (TRE)

Intervention Type: BEHAVIORAL

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

Regular diet

Intervention Type: BEHAVIORAL

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

Interventions

Time restricted eating (TRE)

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

Intervention Type: BEHAVIORAL

Regular diet

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Heart Foundation

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels P. Riksen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL80950.091.22

Identifier Type: -

Identifier Source: org_study_id