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| Name | Class |
|---|---|
| Ministry of Higher Education, Malaysia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ad-libitum eating duration | No Intervention | 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. | |
| Time-restricted eating (TRE) duration | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating 10-hr | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | unit: kg | 4 weeks (pre- & post intervention) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of weekly compliance to intervention | Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100% | 4 weeks |
| Change in caloric intake | Dietary energy consumption, unit: kcal/day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mazuin Kamarul Zaman, MMed Sc | Contact | +60332564397 | mazuin0233@uitm.edu.my | |
| Nur Islami Mohd Fahmi Teng, PhD | Contact | 60332584540 |
| Name | Affiliation | Role |
|---|---|---|
| Mazuin Kamarul Zaman, MMed Sc | Universiti Teknologi Mara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusat Perkhidmatan Klinikal (CTC) UiTM | Recruiting | Kuala Selangor | Malaysia |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003327 | Coronary Disease |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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) |
| 4 weeks (pre- & post intervention) |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |