Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk
NCT04243746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2022-05-18
Summary
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:
1. Longer study duration of 6 months.
2. This is the first study amongst the Asian population.
3. 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.
4. 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.
Conditions
- Obesity
- Metabolic Syndrome
- Pre Diabetes
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
RCSI & UCD Malaysia Campus
lead OTHER
Principal Investigators
-
Kooi Yau Chean · RCSI & UCD Malaysia Campus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-03-03
- Primary Completion
- 2022-03-30
- Completion
- 2022-03-30
Countries
- Malaysia
Study Locations
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