Status:
RECRUITING
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
Lead Sponsor:
Universiti Teknologi Mara
Collaborating Sponsors:
Ministry of Higher Education, Malaysia
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 s...
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 chang...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06007950
Start Date
September 1 2023
End Date
September 1 2025
Last Update
July 18 2024
Active Locations (1)
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1
Pusat Perkhidmatan Klinikal (CTC) UiTM
Kuala Selangor, Malaysia