ObesityTREATYNCT03745612
Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)
A study testing Time restricted feeding and Continuous Energy Restriction in people with Obesity and Time Restricted Feeding, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Time Restricted Feeding, Weight Loss
- What is being tested?
- Time restricted feeding and Continuous Energy Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2018to 28 Jul 2021
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male of female aged between 18 and 75 years old;
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Who cannot join
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
Show all 13Show fewer
- History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
- Women who are pregnant or plan to become pregnant;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months compared to continuous energy restriction (CER).
- Conditions
- Obesity, Time Restricted Feeding, Weight Loss, Calorie Restriction
- Being tested
- Time restricted feeding, Continuous Energy Restriction
- Medical subject headings
- Obesity, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
Continuous Energy RestrictionBehavioural
Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.
| Study group | Role | What they receive |
|---|---|---|
| TRF | Experimental | Time restricted feeding Receives: Behavioral: Time restricted feeding |
| CER | Active comparator | continuous energy restriction Receives: Behavioral: Continuous Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight over 12 months
Measured: Baseline to 12 months
Secondary outcomes (13)
Change in body composition
Measured: Baseline to 12 months
Change in waist circumference
Measured: Baseline to 12 months
Change in liver fat
Measured: Baseline to 12 months
Change in visceral fat
Measured: Baseline to 12 months
Change in HbA1c
Measured: Baseline to 12 months
Change in Blood pressure
Measured: Baseline to 12 months
Change in blood lipids
Measured: Baseline to 12 months
Change in insulin sensitivity
Measured: Baseline to 12 months
Change in β cell function
Measured: Baseline to 12 months
Change in pulse wave velocity (PWV)
Measured: Baseline to 12 months
Depression measured by the Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline to 12 months
Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)
Measured: Baseline to 12 months
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start30 Nov 2018
- Primary completion24 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huijie Zhang, MD,PhD, Principal investigator, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745612
- Sponsor's protocol ID
- NFEC-2018-145
- Acronym
- TREATY
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2018
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.
PubMed 35443107
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03745612
- Acronym / sponsor ID
- TREATY / NFEC-2018-145
- Conditions
- Obesity, Time Restricted Feeding, Weight Loss, Calorie Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 19 Nov 2018 (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.
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months compared to continuous energy restriction (CER).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRF | Experimental | Behavioral: Time restricted feedingTime restricted feeding |
| CER | Active comparator | Behavioral: Continuous Energy Restrictioncontinuous energy restriction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male of female aged between 18 and 75 years old;
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Key exclusion criteria (13 listed)
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
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 feedingParticipants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm). | Behavioural | TRF |
| Continuous Energy RestrictionParticipants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time. | Behavioural | CER |
Primary outcome
Change in body weight over 12 months
Time frame: Baseline to 12 months
13 secondary outcomes
Change in body composition
Time frame: Baseline to 12 months
Change in waist circumference
Time frame: Baseline to 12 months
Change in liver fat
Time frame: Baseline to 12 months
Change in visceral fat
Time frame: Baseline to 12 months
Change in HbA1c
Time frame: Baseline to 12 months
Change in Blood pressure
Time frame: Baseline to 12 months
Change in blood lipids
Time frame: Baseline to 12 months
Change in insulin sensitivity
Time frame: Baseline to 12 months
Change in β cell function
Time frame: Baseline to 12 months
Change in pulse wave velocity (PWV)
Time frame: Baseline to 12 months
Depression measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to 12 months
Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)
Time frame: Baseline to 12 months
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Time frame: Baseline to 12 months
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 15 Nov 2023.
- Results publication: PubMed 35443107Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.
- Individual participant dataSharing planned: No
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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.
Huijie Zhang, MD,PhD principal investigator
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
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 and Continuous Energy Restriction in people with Obesity and Time Restricted Feeding, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 2 inclusion and 13 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 15 Nov 2023. 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 China. 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?
Change in body weight over 12 months (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745612, which also lists 1 linked publication.
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 15 Nov 2023.