Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007950
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-11
Brief Title:
Time-restricted Eating Study TRES Impacts on Anthropometric Cardiometabolic and Cardiovascular Health
Sponsor:
Universiti Teknologi Mara
Organization:
Universiti Teknologi Mara
Study Overview
Official Title:
Impacts of Time-Restricted Eating on Weight Cardiometabolic and Cardiovascular Health in Patients With Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRES
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 2What 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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None