Nonalcoholic Fatty Liver DiseaseTREATY-FLDNCT04988230
Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study
A study testing Time restricted feeding and Continuous Energy Restriction in people with Nonalcoholic Fatty Liver Disease, 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 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- 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
- 88 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 30 Dec 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
- Man or women aged≥18 years;
- Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Who cannot join
- History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- History of HIV, 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);
- Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
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- 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;
- 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 Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month 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 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Time restricted feeding, Continuous Energy Restriction
- Keywords
- Nonalcoholic Fatty Liver Disease, Time restricted feeding, Calorie restriction
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Intermittent Fasting
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 restriction on feeding time.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Feeding | Experimental | 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). Receives: Behavioral: Time restricted feeding |
| Continuous Energy Restriction | Active comparator | Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time. Receives: Behavioral: Continuous Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intrahepatic fat content
Intrahepatic fat content will be assessed by MR mDixon-Quant
Measured: Baseline,month 6, month 12.
Secondary outcomes (10)
Change in liver fiber
Liver fiber will be assessed by liver Fibrotouch
Measured: Baseline,month 6, month 12.
Change in visceral fat
Visceral fat will be assessed by abdominal CT scan
Measured: Baseline,month 6, month 12.
Change in body fat
Body fat will be assessed by whole-body dual x-ray system
Measured: Baseline,month 6, month 12.
Change in waist circumference
Measured: Baseline,month 6, month 12.
Change in body weight
Measured: Baseline,month 6, month 12.
Change in HbA1c level
Measured: Baseline,month 6, month 12.
Change in Systolic blood pressure
Measured: Baseline,month 6, month 12.
Change in LDL-c level
Measured: Baseline,month 6, month 12.
Change in serum ALT level
Measured: Baseline,month 6, month 12.
Change in insulin sensitivity
Insulin sensitivity will be assessed by HOMA-IR
Measured: Baseline,month 6, month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Jul 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 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 Nonalcoholic Fatty Liver DiseaseStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijie Zhang, Nanfang Hospital, Southern Medical University
- Investigators
- Huijie Zhang, MD,PhD, Study chair, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988230
- Sponsor's protocol ID
- NFEC-2018-160R
- Acronym
- TREATY-FLD
- Status last verified
- Apr 2022
- First submitted
- 31 Jul 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.
PubMed 36930148
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04988230
- Acronym / sponsor ID
- TREATY-FLD / NFEC-2018-160R
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic Fatty Liver Disease, Time restricted feeding, Calorie restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 3 Aug 2021 (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 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 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 |
|---|---|---|
| Time Restricted Feeding | Experimental | Behavioral: 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). |
| Continuous Energy Restriction | Active comparator | Behavioral: Continuous Energy RestrictionParticipants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or women aged≥18 years;
- Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Key exclusion criteria (15 listed)
- History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- History of HIV, 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);
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 | Time Restricted Feeding |
| Continuous Energy RestrictionParticipants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time. | Behavioural | Continuous Energy Restriction |
Primary outcome
Change in intrahepatic fat content
Time frame: Baseline,month 6, month 12.
Intrahepatic fat content will be assessed by MR mDixon-Quant
10 secondary outcomes
Change in liver fiber
Time frame: Baseline,month 6, month 12.
Change in visceral fat
Time frame: Baseline,month 6, month 12.
Change in body fat
Time frame: Baseline,month 6, month 12.
Change in waist circumference
Time frame: Baseline,month 6, month 12.
Change in body weight
Time frame: Baseline,month 6, month 12.
Change in HbA1c level
Time frame: Baseline,month 6, month 12.
Change in Systolic blood pressure
Time frame: Baseline,month 6, month 12.
Change in LDL-c level
Time frame: Baseline,month 6, month 12.
Change in serum ALT level
Time frame: Baseline,month 6, month 12.
Change in insulin sensitivity
Time frame: Baseline,month 6, month 12.
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 6 Apr 2022.
- Derived from this study: PubMed 36930148Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.
- Individual participant dataSharing planned: Undecided
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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 study chair
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 Nonalcoholic Fatty Liver Disease, 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 3 inclusion and 15 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 6 Apr 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 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 intrahepatic fat content (time frame: Baseline,month 6, month 12.). 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 NCT04988230, 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 6 Apr 2022.