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

NCT ID: NCT06007950

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-30

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 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.

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ad-libitum eating duration

24 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Time-restricted eating (TRE) duration

24 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.

Group Type: EXPERIMENTAL

Time-restricted eating 10-hr

Intervention Type: BEHAVIORAL

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.

Interventions

Time-restricted eating 10-hr

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Higher Education, Malaysia

OTHER

Sponsor Role: collaborator

Universiti Teknologi Mara

OTHER

Sponsor Role: lead

Responsible Party

MAZUIN KAMARUL ZAMAN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mazuin Kamarul Zaman, MMed Sc

Role: PRINCIPAL_INVESTIGATOR

Universiti Teknologi Mara

Locations

Pusat Perkhidmatan Klinikal (CTC) UiTM

Kuala Selangor, , Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Mazuin Kamarul Zaman, MMed Sc

Role: CONTACT

mazuin0233@uitm.edu.my

+60332564397

Nur Islami Mohd Fahmi Teng, PhD

Role: CONTACT

60332584540

Facility Contacts

Sazzli Shahlan Kasim, MBBCh

Role: primary

+60361265000

Other Identifiers

TRES2301

Identifier Type: -

Identifier Source: org_study_id