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The obesity rate in Malaysia is higher than the average world obesity rate. Central obesity is a component of metabolic syndrome (MetS) which is also made up of dyslipidemia, impaired glucose tolerance, and hypertension. MetS is a continuum in the risk of developing cardiometabolic complication. Time Restricted Feeding (TRF) involves an extended physiological overnight fast. Researchers believe that the timing of meal intake that matches with the circadian rhythms is as important as the calories intake to prevent obesity and its complications. The investigators hypothesize that TRF is effective in weight control and improvement of metabolic severity. Subjects will be randomized into either the control group, which practices QQH dietary plan or intervention group, which practices TRF as an adjunct to QQH dietary plan.
Subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety of TRF.
This study intends to fill a few research gaps as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH) | Experimental | Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH). |
|
| Standard Malaysian Healthy Plate (QQH) | Active Comparator | Subjects practise the QQH dietary plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Feeding | Behavioral | Subjects practise TRF (2-3 meals) as an adjunct to the QQH healthy plate diet. Subjects of the intervention group can eat during the pre-determined 8-12 hours eating window, but they are only allowed to drink water and calorie-free drinks for the remaining 12-16 hours. Subjects are allowed to decide the time of their first and the last meal of the day as long as they eat within the 8-12 hour window period. However, skipping breakfast and having late dinner are discouraged. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Mean body weight change will be calculated. | baseline - 24 weeks |
| Systolic BP (mmHg) | This is a parameter for the calculation of metabolic syndrome severity score. | baseline - 24 weeks |
| Fasting blood sugar (mmol/L) | This is a parameter for the calculation of metabolic syndrome severity score. | baseline - 24 weeks |
| Waist circumference (cm) | This is a parameter for the calculation of metabolic syndrome severity score. | baseline - 24 weeks |
| Serum triglyceride(mmol/L) | This is a parameter for the calculation metabolic syndrome severity score. | baseline - 24 weeks |
| Serum high density lipoprotein (HDL) (mmol/L) | This is a parameter for the calculation metabolic syndrome severity score. | baseline - 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of fasting hours per day | For assessment of adherence | baseline - 24 weeks |
| Number of days achieving TRF | For assessment of adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kooi Yau Chean | RCSI & UCD Malaysia Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penang General Hospital | George Town | Pulau Pinang | 10450 | Malaysia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | Subjects practice the QQH healthy plate diet as per guidelines set by the Health Ministry the guidelines.QQH refers to a normal food plate (23cm in diameter), divided into a quarter of rice (carbohydrates), a quarter of meat (protein) and a half plate of vegetables and fruits. Additionally, no calories specification is required and snacks are discouraged. |
|
| baseline-24 weeks |
| Incidence of treatment-emergent adverse events [Safety ] | baseline-24 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006943 | Hyperglycemia |