Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

NCT ID: NCT04243746

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2022-03-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)

Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).

Group Type: EXPERIMENTAL

Time Restricted Feeding

Intervention Type: 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.

Standard Malaysian Healthy Plate (QQH)

Subjects practise the QQH dietary plan.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 20-59 years of age

2. BMI 27.5kg/m2 - 39.9kg/m2

3. Smart phone users

4. Willing to lose weight

5. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria

1. Those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects.

2. Women who are pregnant or breastfeeding.

3. Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months.

4. Subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes.

5. Those currently on medication for chronic illness.

6. Permanent night shift worker

7. Those who need to practise Ramadan fasting during the period of this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RCSI & UCD Malaysia Campus

OTHER

Sponsor Role: lead

Responsible Party

Dr Chean Kooi Yau

Principal investigator, senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kooi Yau Chean

Role: PRINCIPAL_INVESTIGATOR

RCSI & UCD Malaysia Campus

Locations

Penang General Hospital

George Town, Pulau Pinang, Malaysia

Countries

Malaysia

Other Identifiers

TRF168 001

Identifier Type: -

Identifier Source: org_study_id