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

Primary Purpose

Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Time-restricted eating 10-hr
Sponsored by
Universiti Teknologi Mara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring coronary heart disease, time-restricted eating, intermittent fasting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusat Perkhidmatan Klinikal (CTC) UiTM

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Ad-libitum eating duration

Time-restricted eating (TRE) duration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in weight
unit: kg

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2023
Last Updated
August 22, 2023
Sponsor
Universiti Teknologi Mara
Collaborators
Ministry of Higher Education, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT06007950
Brief Title
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
Acronym
TRES
Official Title
Impacts of Time-Restricted Eating on Weight, Cardiometabolic and Cardiovascular Health in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara
Collaborators
Ministry of Higher Education, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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; 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
coronary heart disease, time-restricted eating, intermittent fasting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ad-libitum eating duration
Arm Type
No Intervention
Arm Description
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.
Arm Title
Time-restricted eating (TRE) duration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating 10-hr
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in weight
Description
unit: kg
Time Frame
4 weeks (pre- & post intervention)
Secondary Outcome Measure Information:
Title
Change in lean body mass
Description
unit : kg
Time Frame
4 weeks (pre- & post intervention)
Title
Change in fat mass
Description
unit : kg
Time Frame
4 weeks (pre- & post intervention)
Title
Change in fasting glucose concentration
Description
Glycaemic biomarker, unit: mmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in fasting insulin concentration
Description
Glycaemic biomarker, unit:pmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in total cholesterol concentration
Description
Lipid metabolism biomarker, unit: mmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in high-density lipoprotein concentration
Description
Lipid metabolism biomarker, unit: mmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in low-density lipoprotein concentration
Description
Lipid metabolism biomarker, unit: mmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in triglycerides concentration
Description
Lipid metabolism biomarker, unit: mmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in C-reactive protein concentration
Description
Inflammatory biomarkers, unit: mg/dL
Time Frame
4 weeks (pre- & post intervention)
Title
Change in Malondialdehyde (MDA) level
Description
Oxidative stress Lipid peroxidation, unit:μmol/L
Time Frame
4 weeks (pre- & post intervention)
Title
Change in flow-mediated dilatation,
Description
Endothelial function, unit:%
Time Frame
4 weeks (pre- & post intervention)
Title
Change in Brachial-ankle pulse wave velocity
Description
arterial stiffness, unit:m/s
Time Frame
4 weeks (pre- & post intervention)
Title
Change in perceived appetite
Description
Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)
Time Frame
4 weeks (pre- & post intervention)
Title
Adverse event monitoring
Description
Report of incidence of adverse events for safety monitoring
Time Frame
4 weeks
Title
Change in Hemoglobin level
Description
Safety monitoring, unit: g/dl
Time Frame
4 weeks
Title
Change in sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) scale, A higher score indicates a worse sleep quality. PSQI score >5= poor sleep.
Time Frame
4 weeks (pre- & post intervention)
Title
Change in physical activity
Description
Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes
Time Frame
4 weeks (pre- & post intervention)
Other Pre-specified Outcome Measures:
Title
Rate of weekly compliance to intervention
Description
Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%
Time Frame
4 weeks
Title
Change in caloric intake
Description
Dietary energy consumption, unit: kcal/day
Time Frame
4 weeks (pre- & post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mazuin Kamarul Zaman, MMed Sc
Phone
+60332564397
Email
mazuin0233@uitm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Islami Mohd Fahmi Teng, PhD
Phone
60332584540
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazuin Kamarul Zaman, MMed Sc
Organizational Affiliation
Universiti Teknologi Mara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusat Perkhidmatan Klinikal (CTC) UiTM
City
Kuala Selangor
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sazzli Shahlan Kasim, MBBCh
Phone
+60361265000
First Name & Middle Initial & Last Name & Degree
Nur Islami Mohd Fahmi Teng, PhD
First Name & Middle Initial & Last Name & Degree
Norsham Juliana, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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