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

NCT06007950 | Recruiting

• 1 other identifier: TRES2301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

coronary heart disease; time-restricted eating; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• Change in weight

  unit: kg

  4 weeks (pre- & post intervention)

Secondary Outcomes (17)

• Change in lean body mass

  4 weeks (pre- & post intervention)

• Change in fat mass

  4 weeks (pre- & post intervention)

• Change in fasting glucose concentration

  4 weeks (pre- & post intervention)

• Change in fasting insulin concentration

  4 weeks (pre- & post intervention)

• Change in total cholesterol concentration

  4 weeks (pre- & post intervention)

Other Outcomes (2)

• Rate of weekly compliance to intervention

  4 weeks

• Change in caloric intake

  4 weeks (pre- & post intervention)

Study Arms (2)

Ad-libitum eating duration

NO INTERVENTION

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.

Time-restricted eating (TRE) duration

EXPERIMENTAL

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.

Behavioral: Time-restricted eating 10-hr

Interventions

Time-restricted eating 10-hr 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.

Time-restricted eating (TRE) duration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Pusat Perkhidmatan Klinikal (CTC) UiTM

Kuala Selangor, Malaysia

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Coronary Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Fasting; Feeding Behavior; Behavior

Study Officials

• Mazuin Kamarul Zaman, MMed Sc

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mazuin Kamarul Zaman, MMed Sc

CONTACT

+60332564397; mazuin0233@uitm.edu.my

Nur Islami Mohd Fahmi Teng, PhD

CONTACT

60332584540

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)