Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity; Pre Diabetes
• Interventions: Behavioral: Standard Care; Behavioral: Time Restricted Feeding

• Registration Number: NCT04243746
• Lead Sponsor: RCSI & UCD Malaysia Campus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-28
• Study Start: 2020-03-03
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Malaysian Healthy Plate (QQH)	Standard Care	Subjects practise the QQH dietary plan.
Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)	Time Restricted Feeding	Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).

Primary Outcome Measures

Name	Time	Method
Fasting blood sugar (mmol/L)	baseline - 24 weeks	This is a parameter for the calculation of metabolic syndrome severity score.
Serum triglyceride(mmol/L)	baseline - 24 weeks	This is a parameter for the calculation metabolic syndrome severity score.
Systolic BP (mmHg)	baseline - 24 weeks	This is a parameter for the calculation of metabolic syndrome severity score.
Body weight (kg)	baseline - 24 weeks	Mean body weight change will be calculated.
Waist circumference (cm)	baseline - 24 weeks	This is a parameter for the calculation of metabolic syndrome severity score.
Serum high density lipoprotein (HDL) (mmol/L)	baseline - 24 weeks	This is a parameter for the calculation metabolic syndrome severity score.

Secondary Outcome Measures

Name	Time	Method
Number of fasting hours per day	baseline - 24 weeks	For assessment of adherence
Number of days achieving TRF	baseline-24 weeks	For assessment of adherence
Incidence of treatment-emergent adverse events [Safety ]	baseline-24 weeks

Trial Locations

Locations (1)

Penang General Hospital; 🇲🇾 George Town, Penang, Malaysia