NCT04243746

Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: RCSI & UCD Malaysia Campus · Academic / Other
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2020-01-28
• Last updated: 2022-05-18

Locations

1 site across 1 country: Malaysia