ObesityNCT04243746
Time Restricted Feeding to Reduce Weight and Cardiometabolic Risk
A study testing Time Restricted Feeding in people with Obesity and Metabolic Syndrome, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Pre Diabetes
- What is being tested?
- Time Restricted Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Mar 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity, Metabolic Syndrome, Pre Diabetes
- Being tested
- Time Restricted Feeding, Standard Care
- Medical subject headings
- Obesity, Metabolic Syndrome, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH) | Experimental | Subjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH). Receives: Behavioral: Time Restricted Feeding |
| Standard Malaysian Healthy Plate (QQH) | Active comparator | Subjects practise the QQH dietary plan. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Mean body weight change will be calculated.
Measured: baseline - 24 weeks
Systolic BP (mmHg)
This is a parameter for the calculation of metabolic syndrome severity score.
Measured: baseline - 24 weeks
Fasting blood sugar (mmol/L)
This is a parameter for the calculation of metabolic syndrome severity score.
Measured: baseline - 24 weeks
Waist circumference (cm)
This is a parameter for the calculation of metabolic syndrome severity score.
Measured: baseline - 24 weeks
Serum triglyceride(mmol/L)
This is a parameter for the calculation metabolic syndrome severity score.
Measured: baseline - 24 weeks
Serum high density lipoprotein (HDL) (mmol/L)
This is a parameter for the calculation metabolic syndrome severity score.
Measured: baseline - 24 weeks
Secondary outcomes (3)
Number of fasting hours per day
For assessment of adherence
Measured: baseline - 24 weeks
Number of days achieving TRF
For assessment of adherence
Measured: baseline-24 weeks
Incidence of treatment-emergent adverse events [Safety ]
Measured: baseline-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start3 Mar 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- RCSI & UCD Malaysia Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Chean Kooi Yau, RCSI & UCD Malaysia Campus
- Investigators
- Kooi Yau Chean, Principal investigator, RCSI & UCD Malaysia Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243746
- Sponsor's protocol ID
- TRF168 001
- Status last verified
- May 2022
- First submitted
- 19 Jan 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults
- ClinicalTrials.gov ID
- NCT04243746
- Acronym / sponsor ID
- TRF168 001
- Conditions
- Obesity, Metabolic Syndrome, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- RCSI & UCD Malaysia CampusUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH) | Experimental | Behavioral: Time Restricted FeedingSubjects practise time restricted feeding (TRF) in addition to the Standard Malaysian Healthy Plate (QQH). |
| Standard Malaysian Healthy Plate (QQH) | Active comparator | Behavioral: Standard CareSubjects practise the QQH dietary plan. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted FeedingSubjects 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. | Behavioural | Time Restricted Feeding +Standard Malaysian Healthy Plate(QQH) |
| Standard CareSubjects 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. | Behavioural | Standard Malaysian Healthy Plate (QQH) |
Primary outcome
Body weight (kg)
Time frame: baseline - 24 weeks
Mean body weight change will be calculated.
Systolic BP (mmHg)
Time frame: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Fasting blood sugar (mmol/L)
Time frame: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Waist circumference (cm)
Time frame: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Serum triglyceride(mmol/L)
Time frame: baseline - 24 weeks
This is a parameter for the calculation metabolic syndrome severity score.
Serum high density lipoprotein (HDL) (mmol/L)
Time frame: baseline - 24 weeks
This is a parameter for the calculation metabolic syndrome severity score.
3 secondary outcomes
Number of fasting hours per day
Time frame: baseline - 24 weeks
Number of days achieving TRF
Time frame: baseline-24 weeks
Incidence of treatment-emergent adverse events [Safety ]
Time frame: baseline-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kooi Yau Chean principal investigator
RCSI & UCD Malaysia Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Feeding in people with Obesity and Metabolic Syndrome, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: baseline - 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.