Time Restricted FeedingSIGNATURENCT05639244
Time Restricted Eating and Innate Immunity
A study testing Time restricted eating (TRE) and Regular diet in people with Time Restricted Feeding and Myocardial Infarction, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Time Restricted Feeding, Myocardial Infarction, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Time restricted eating (TRE) and Regular diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6500 GB
About this study
Official title: Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease
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.
Read the 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.
- Being tested
- Time restricted eating (TRE), Regular diet
- Keywords
- time restricted eating
- Medical subject headings
- Intermittent Fasting, Myocardial Infarction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eating (TRE)Behavioural
Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks.
Regular dietBehavioural
Participants have to consume their regular diet within an unrestricted time period for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Time restricted eating (TRE); Behavioral: Regular diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start17 Nov 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted FeedingStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Niels P. Riksen, Prof. Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639244
- Sponsor's protocol ID
- NL80950.091.22
- Acronym
- SIGNATURE
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05639244
- Acronym / sponsor ID
- SIGNATURE / NL80950.091.22
- Keywords
- time restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| First TRE, then regular diet | Other | Behavioral: Time restricted eating (TRE), Behavioral: Regular dietThis 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. |
| First regular diet, then TRE | Other | Behavioral: Time restricted eating (TRE), Behavioral: Regular dietThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eating (TRE)Participants have to consume their regular food intake during a 6 hour period per day for 2 weeks. | Behavioural | First TRE, then regular diet, First regular diet, then TRE |
| Regular dietParticipants have to consume their regular diet within an unrestricted time period for 2 weeks | Behavioural | First TRE, then regular diet, First regular diet, then TRE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Time Restricted Feeding
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Recruiting
Time-Restricted Eating After Bariatric Surgery
Obesity & Overweight, Bariatric Surgery
Active, not recruiting
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Diabetes Mellitus, Type 2, Time Restricted Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels P. Riksen, Prof. Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating (TRE) and Regular diet in people with Time Restricted Feeding and Myocardial Infarction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.