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Myocardial InfarctionTRESNCT06007950

Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health

A study testing Time-restricted eating 10-hr in people with Myocardial Infarction, run by Universiti Teknologi Mara at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to learn about the effects of time-restricted eating in patients with history of acute coronary syndrome. The main questions it aims to answer are: 1) Is 10-hr TRE safe and feasible for patients with ACS; 2)What are the impacts of 10-hr TRE on anthropometric measurements… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Time-restricted eating 10-hr
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteMalaysia
Study dates
1 Sep 2023to Sep 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult, 18- 65 years old.
  • Had history of acute coronary syndrome (ACS)
  • Clinically stable
  • Self-reported eating window of at least 12 h per day.

Who cannot join

  • Severe obesity (body mass index ≥40 kg m-2).
  • Unstable weight in the past three months (gain or lose more than 4 kg of weight).
  • Unstable cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that may compromise study validity.
  • Any medications or supplements known to change sleep, circadian rhythms, or metabolism.
  • Pregnant or lactating women.
  • Perform overnight shift work more than one day/week on average.
Show all 17Show fewer
  • Regularly fasted for more than 15 hours/day or having completed twelve 24-hr fasts within the past three months).
  • Active use of tobacco or illicit drug or history of treatment for alcohol abuse.
  • Type I diabetes or diabetic, treated with insulin.
  • Use of anti-obesity drugs or other drugs affecting body weight.
  • Currently enrolled in weight loss or management programme, including surgical intervention.
  • Severe kidney failure (glomerular filtration rate (GFR) <30 mL/min).
  • Eating disorder or current diagnosis of uncontrolled psychiatric illness, which may impair study involvement.
  • Malignancy undergoing active treatment.
  • Had gastrointestinal surgery or impaired nutrient absorption.
  • Travelled more than two time zones away two months prior to enrolling in the trial or will travel more than two time zones away during the study period.
  • Concurrent participation in other interventional studies

Trial locations and contacts

1 site in 1 country.

Mazuin Kamarul Zaman, MMed Sc contact

+60332564397

mazuin0233@uitm.edu.my

Nur Islami Mohd Fahmi Teng, PhD contact

60332584540

Malaysia1 site, 1 recruiting

  • Pusat Perkhidmatan Klinikal (CTC) UiTM

    Kuala Selangor

    Sazzli Shahlan Kasim, MBBCh, +60361265000

    Nur Islami Mohd Fahmi Teng, PhD

    Recruiting

Other trials in Malaysia

About this study

Official title: Impacts of Time-Restricted Eating on Weight, Cardiometabolic and Cardiovascular Health in Patients With Acute Coronary Syndrome

The goal of this clinical trial is to learn about the effects of time-restricted eating in patients with history of acute coronary syndrome. The main questions it aims to answer are: 1) Is 10-hr TRE safe and feasible for patients with ACS; 2)What are the impacts of 10-hr TRE on anthropometric measurements, cardiometabolic health and cardiovascular health compared to ad libitum eating in patients with ACS?. Participants will be asked to limit eating duration to 10 hours daily.

Read the detailed description

Justification: The effects of TRE on humans varies results, with some showing improvements in weight loss, insulin sensitivity, and cardiovascular markers, while others exhibiting no significant changes. TRE studies on metabolically altered individuals especially patients with heart diseases are limited.

Written approval of the study has been obtained from the Universiti Teknologi MARA Ethics Committee before commencement of this study.

The TRES study utilizes an investigator-led, pragmatic, parallel, randomized, single-blinded clinical trial design to evaluate the safety, feasibility, and effectiveness of a 10-hour time-restricted eating (TRE) intervention compared to unrestricted eating in patients diagnosed with acute coronary syndrome. The study aims to assess the impact of TRE on anthropometric measurements, as well as cardiometabolic and cardiovascular health outcomes. The duration of the randomized controlled trial (RCT) spans a period of five weeks. The trial consisted of a baseline period of one week, which was then followed by a four-week intervention phase. The participants will be assigned randomly to either the TRE (Time-Restricted Eating) group or the control group, which involves ad libitum eating. They will be instructed to adhere to their allotted eating duration during the four-week intervention period.

Being tested
Time-restricted eating 10-hr
Keywords
coronary heart disease, time-restricted eating, intermittent fasting
Medical subject headings
Myocardial Infarction, Coronary Disease, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-restricted eating 10-hrBehavioural

    Time-restricted eating is a form of intermittent fasting. In this study, 10-hr TRE will be employed, where eating duration is limited to 10 hours. Participants are allowed to consume non-caloric beverages during fasting period.

Study groups in NCT06007950
Study groupRoleWhat they receive
Ad-libitum eating durationNo intervention24 patients will be randomly assigned to the control group. Participants will be asked to continue usual eating duration. Participants will receive the standard care and heart-healthy nutrition education.
Time-restricted eating (TRE) durationExperimental24 patients will be randomly assigned to the intervention group. Participants in this arm will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and heart-healthy nutrition education.
Receives: Behavioral: Time-restricted eating 10-hr

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight

    unit: kg

    Measured: 4 weeks (pre- & post intervention)

Secondary outcomes (17)

  1. Change in lean body mass

    unit : kg

    Measured: 4 weeks (pre- & post intervention)

  2. Change in fat mass

    unit : kg

    Measured: 4 weeks (pre- & post intervention)

  3. Change in fasting glucose concentration

    Glycaemic biomarker, unit: mmol/L

    Measured: 4 weeks (pre- & post intervention)

  4. Change in fasting insulin concentration

    Glycaemic biomarker, unit:pmol/L

    Measured: 4 weeks (pre- & post intervention)

  5. Change in total cholesterol concentration

    Lipid metabolism biomarker, unit: mmol/L

    Measured: 4 weeks (pre- & post intervention)

  6. Change in high-density lipoprotein concentration

    Lipid metabolism biomarker, unit: mmol/L

    Measured: 4 weeks (pre- & post intervention)

  7. Change in low-density lipoprotein concentration

    Lipid metabolism biomarker, unit: mmol/L

    Measured: 4 weeks (pre- & post intervention)

  8. Change in triglycerides concentration

    Lipid metabolism biomarker, unit: mmol/L

    Measured: 4 weeks (pre- & post intervention)

  9. Change in C-reactive protein concentration

    Inflammatory biomarkers, unit: mg/dL

    Measured: 4 weeks (pre- & post intervention)

  10. Change in Malondialdehyde (MDA) level

    Oxidative stress Lipid peroxidation, unit:μmol/L

    Measured: 4 weeks (pre- & post intervention)

  11. Change in flow-mediated dilatation,

    Endothelial function, unit:%

    Measured: 4 weeks (pre- & post intervention)

  12. Change in Brachial-ankle pulse wave velocity

    arterial stiffness, unit:m/s

    Measured: 4 weeks (pre- & post intervention)

  13. Change in perceived appetite

    Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)

    Measured: 4 weeks (pre- & post intervention)

  14. Adverse event monitoring

    Report of incidence of adverse events for safety monitoring

    Measured: 4 weeks

  15. Change in Hemoglobin level

    Safety monitoring, unit: g/dl

    Measured: 4 weeks

  16. Change in sleep quality

    Pittsburgh Sleep Quality Index (PSQI) scale, A higher score indicates a worse sleep quality. PSQI score >5= poor sleep.

    Measured: 4 weeks (pre- & post intervention)

  17. Change in physical activity

    Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes

    Measured: 4 weeks (pre- & post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007950
Sponsor's protocol ID
TRES2301
Acronym
TRES
Status last verified
Jul 2024
First submitted
11 Aug 2023
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Time-restricted eating 10-hr in people with Myocardial Infarction, run by Universiti Teknologi Mara at 1 site in Malaysia.

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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Jul 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 Malaysia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mazuin Kamarul Zaman, MMed Sc (+60332564397, mazuin0233@uitm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight (time frame: 4 weeks (pre- & post intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007950.

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 18 Jul 2024.

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