Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk
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|ClinicalTrials.gov Identifier: NCT04243746|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
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:
- Longer study duration of 6 months.
- This is the first study amongst the Asian population.
- Adherence level to TRF in real life setting is measured. This information can potentially predict the intensity level of TRF that are feasible for practice in real life and also its association with the efficacy of TRF.
- TRF is defined as eating within a≤12-hour period and fasting for at least 12 hours per day. This is the shortest fasting window studied so far.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Metabolic Syndrome Pre Diabetes||Behavioral: Time Restricted Feeding Behavioral: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)
Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).
Behavioral: Time Restricted Feeding
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.
Active Comparator: Standard Malaysian Healthy Plate (QQH)
Subjects practise the QQH dietary plan.
Behavioral: Standard Care
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.
- Body weight (kg) [ Time Frame: baseline - 24 weeks ]Mean body weight change will be calculated.
- Systolic BP (mmHg) [ Time Frame: baseline - 24 weeks ]This is a parameter for the calculation of metabolic syndrome severity score.
- Fasting blood sugar (mmol/L) [ Time Frame: baseline - 24 weeks ]This is a parameter for the calculation of metabolic syndrome severity score.
- Waist circumference (cm) [ Time Frame: baseline - 24 weeks ]This is a parameter for the calculation of metabolic syndrome severity score.
- Serum triglyceride(mmol/L) [ Time Frame: baseline - 24 weeks ]This is a parameter for the calculation metabolic syndrome severity score.
- Serum high density lipoprotein (HDL) (mmol/L) [ Time Frame: baseline - 24 weeks ]This is a parameter for the calculation metabolic syndrome severity score.
- Number of fasting hours per day [ Time Frame: baseline - 24 weeks ]For assessment of adherence
- Number of days achieving TRF [ Time Frame: baseline-24 weeks ]For assessment of adherence
- Incidence of treatment-emergent adverse events [Safety ] [ Time Frame: baseline-24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243746
|Contact: Kooi Yau Chean||+6042171999 ext firstname.lastname@example.org|
|Principal Investigator:||Kooi Yau Chean||RCSI & UCD Malaysia Campus|