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

Myocardial Infarction Clinical Trial

— TRES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06007950
• Other study ID #: TRES2301
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Universiti Teknologi Mara
• Contact: Mazuin Kamarul Zaman, MMed Sc
• Phone: +60332564397
• Email: mazuin0233[@]uitm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Pusat Perkhidmatan Klinikal (CTC) UiTM	Kuala Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Teknologi Mara	Ministry of Higher Education Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of weekly compliance to intervention	Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%	4 weeks
Other	Change in caloric intake	Dietary energy consumption, unit: kcal/day	4 weeks (pre- & post intervention)
Primary	Change in weight	unit: kg	4 weeks (pre- & post intervention)
Secondary	Change in lean body mass	unit : kg	4 weeks (pre- & post intervention)
Secondary	Change in fat mass	unit : kg	4 weeks (pre- & post intervention)
Secondary	Change in fasting glucose concentration	Glycaemic biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Secondary	Change in fasting insulin concentration	Glycaemic biomarker, unit:pmol/L	4 weeks (pre- & post intervention)
Secondary	Change in total cholesterol concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Secondary	Change in high-density lipoprotein concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Secondary	Change in low-density lipoprotein concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Secondary	Change in triglycerides concentration	Lipid metabolism biomarker, unit: mmol/L	4 weeks (pre- & post intervention)
Secondary	Change in C-reactive protein concentration	Inflammatory biomarkers, unit: mg/dL	4 weeks (pre- & post intervention)
Secondary	Change in Malondialdehyde (MDA) level	Oxidative stress Lipid peroxidation, unit:µmol/L	4 weeks (pre- & post intervention)
Secondary	Change in flow-mediated dilatation,	Endothelial function, unit:%	4 weeks (pre- & post intervention)
Secondary	Change in Brachial-ankle pulse wave velocity	arterial stiffness, unit:m/s	4 weeks (pre- & post intervention)
Secondary	Change in perceived appetite	Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)	4 weeks (pre- & post intervention)
Secondary	Adverse event monitoring	Report of incidence of adverse events for safety monitoring	4 weeks
Secondary	Change in Hemoglobin level	Safety monitoring, unit: g/dl	4 weeks
Secondary	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)
Secondary	Change in physical activity	Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes	4 weeks (pre- & post intervention)