- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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:
- Longer study duration of 6 months.
- This is the first study amongst the Asian population.
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Penang
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George Town, Penang, Malaysia, 10450
- Penang General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20-59 years of age
- BMI 27.5kg/m2 - 39.9kg/m2
- Smart phone users
- Willing to lose weight
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
Exclusion Criteria:
- 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.
- Women who are pregnant or breastfeeding.
- Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months.
- 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.
- Those currently on medication for chronic illness.
- Permanent night shift worker
- Those who need to practise Ramadan fasting during the period of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH)
Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH).
|
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.
|
Active Comparator: Standard Malaysian Healthy Plate (QQH)
Subjects practise the QQH dietary plan.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight (kg)
Time Frame: baseline - 24 weeks
|
Mean body weight change will be calculated.
|
baseline - 24 weeks
|
Systolic BP (mmHg)
Time Frame: baseline - 24 weeks
|
This is a parameter for the calculation of metabolic syndrome severity score.
|
baseline - 24 weeks
|
Fasting blood sugar (mmol/L)
Time Frame: baseline - 24 weeks
|
This is a parameter for the calculation of metabolic syndrome severity score.
|
baseline - 24 weeks
|
Waist circumference (cm)
Time Frame: baseline - 24 weeks
|
This is a parameter for the calculation of metabolic syndrome severity score.
|
baseline - 24 weeks
|
Serum triglyceride(mmol/L)
Time Frame: baseline - 24 weeks
|
This is a parameter for the calculation metabolic syndrome severity score.
|
baseline - 24 weeks
|
Serum high density lipoprotein (HDL) (mmol/L)
Time Frame: baseline - 24 weeks
|
This is a parameter for the calculation metabolic syndrome severity score.
|
baseline - 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of fasting hours per day
Time Frame: baseline - 24 weeks
|
For assessment of adherence
|
baseline - 24 weeks
|
Number of days achieving TRF
Time Frame: baseline-24 weeks
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For assessment of adherence
|
baseline-24 weeks
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Incidence of treatment-emergent adverse events [Safety ]
Time Frame: baseline-24 weeks
|
baseline-24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kooi Yau Chean, RCSI & UCD Malaysia Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRF168 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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