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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Behavioral: Time-restricted eating 10-hr

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mazuin Kamarul Zaman, MMed Sc; Phone Number: +60332564397; Email: mazuin0233@uitm.edu.my
• Study Contact Backup: Name: Nur Islami Mohd Fahmi Teng, PhD; Phone Number: 60332584540

Study Locations

• Malaysia
  • Kuala Selangor, Malaysia
    • Pusat Perkhidmatan Klinikal (CTC) UiTM
    • Contact: Sazzli Shahlan Kasim, MBBCh; Phone Number: +60361265000
    • Sub-Investigator: Nur Islami Mohd Fahmi Teng, PhD
    • Sub-Investigator: Norsham Juliana, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	unit: kg	4 weeks (pre- & post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lean body mass	unit : kg	4 weeks (pre- & post intervention)
Change in fat mass	unit : kg	4 weeks (pre- & post intervention)
Change in fasting glucose concentration	Glycaemic biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Change in fasting insulin concentration	Glycaemic biomarker, unit:pmol/L	4 weeks (pre- & post intervention)
Change in total cholesterol concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Change in high-density lipoprotein concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Change in low-density lipoprotein concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Change in triglycerides concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Change in C-reactive protein concentration	Inflammatory biomarkers, unit: mg/dL	4 weeks (pre- & post intervention)
Change in Malondialdehyde (MDA) level	Oxidative stress Lipid peroxidation, unit:μmol/L	4 weeks (pre- & post intervention)
Change in flow-mediated dilatation,	Endothelial function, unit:%	4 weeks (pre- & post intervention)
Change in Brachial-ankle pulse wave velocity	arterial stiffness, unit:m/s	4 weeks (pre- & post intervention)
Change in perceived appetite	Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)	4 weeks (pre- & post intervention)
Adverse event monitoring	Report of incidence of adverse events for safety monitoring	4 weeks
Change in Hemoglobin level	Safety monitoring, unit: g/dl	4 weeks
Change in sleep quality	Pittsburgh Sleep Quality Index (PSQI) scale, A higher score indicates a worse sleep quality. PSQI score >5= poor sleep.	4 weeks (pre- & post intervention)
Change in physical activity	Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes	4 weeks (pre- & post intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of weekly compliance to intervention	Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%	4 weeks
Change in caloric intake	Dietary energy consumption, unit: kcal/day	4 weeks (pre- & post intervention)

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara
• Collaborators: Ministry of Higher Education Malaysia
• Investigators: Principal Investigator: Mazuin Kamarul Zaman, MMed Sc, Universiti Teknologi Mara

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: intermittent fasting; coronary heart disease; time-restricted eating
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: TRES2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No