Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

RCSI & UCD Malaysia Campus

Status: Completed

Conditions: Obesity; Pre Diabetes; Metabolic Syndrome

Treatments: Behavioral: Time Restricted Feeding; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04243746

TRF168 001

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)

Experimental group

Description:

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

Treatment:

Behavioral: Time Restricted Feeding

Standard Malaysian Healthy Plate (QQH)

Active Comparator group

Description:

Subjects practise the QQH dietary plan.

Treatment:

Behavioral: Standard Care