Time-restricted Eating Study (TRES): Impacts on Anthropometric,

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06007950
Study type	Interventional
Source	Universiti Teknologi Mara
Contact	Mazuin Kamarul Zaman, MMed Sc
Phone	+60332564397
Email	mazuin0233@uitm.edu.my
Status	Not yet recruiting
Phase	N/A
Start date	September 2023
Completion date	September 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms