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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Behavioral: Time-restricted eating 10-hr


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ad-libitum eating duration<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary heart disease, time-restricted eating, intermittent fasting