Non-Alcoholic Fatty Liver DiseaseNCT05579158
Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
A study testing Mobile application and wearable device and Time-restricted eating in people with Non-Alcoholic Fatty Liver Disease and Time Restricted Feeding, run by Hanyang University at 1 site in South Korea.
Trial summary
In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Time Restricted Feeding, Mobile Technology
- What is being tested?
- Mobile application and wearable device and Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2023to 12 Jan 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 19 years who are willing and able to complete all procedures
- Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))
Who cannot join
- Body mass index (BMI) <23
- Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
- Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
- Significant alcohol intake (>210g/week for men, >140g/week for women)
- Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure > 200/120 mmHg)
- Psychiatric illnesses which limit ability to exercise safely
Show all 9Show fewer
- Diagnosed with diabetes on medication or insulin
- Participation in a weight-loss program within 12 weeks
- MRI contraindications
Trial locations and contacts
1 site in 1 country.
About this study
In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.
- Being tested
- Mobile application and wearable device, Time-restricted eating
- 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.
Mobile application and wearable deviceBehavioural
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
Time-restricted eatingBehavioural
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
| Study group | Role | What they receive |
|---|---|---|
| Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) | Experimental | This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day). Receives: Behavioral: Mobile application and wearable device; Behavioral: Time-restricted eating |
| Mobile application-supported calorie restriction (mCR) | Active comparator | This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of only calorie restriction (500kcal below estimated energy requirement). Receives: Behavioral: Mobile application and wearable device |
| Calorie restriction (CR) | No intervention | Standard of care. This arm receives a brief counseling of calorie restriction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic steatosis (%)
Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
Measured: 16 weeks
Secondary outcomes (14)
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk
Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)
Measured: 16 weeks
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)
Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver
Measured: 16 weeks
Change in body weight (kg)
Evaluate the mean change in body weight (kg)
Measured: 16 weeks
Change in systolic blood pressure (mmHg)
Evaluate the mean change in systolic blood pressure (mmHg)
Measured: 16 weeks
Change in low-density lipoprotein level (mg/dL)
Evaluate the mean change in low-density lipoprotein level (mg/dL)
Measured: 16 weeks
Change in serum alanine aminotransferase level (IU/L)
Evaluate the mean change in serum alanine aminotransferase level (IU/L)
Measured: 16 weeks
Change in hemoglobin A1c level (%)
Evaluate the mean change in hemoglobin A1c level (%)
Measured: 16 weeks
Change in insulin sensitivity
Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)
Measured: 16 weeks
Change in urine microalbumin (mcg/min)
Evaluate the mean change in urine microalbumin (mcg/min)
Measured: 16 weeks
Change in body muscle mass (kg)
Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)
Measured: 16 weeks
Change in liver fibrosis by liver stiffness (kPa)
Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®
Measured: 16 weeks
Change in liver steatosis by controlled attenuation parameter (dB/m)
Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®
Measured: 16 weeks
Change in body weight (kg) at 6 months after the intervention
Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period
Measured: 40 weeks
Change in body weight (kg) at 12 months after the intervention
Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Feb 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
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 Non-Alcoholic Fatty Liver DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health, Korea
- Responsible party
- Principal investigator, Dae Won Jun, Hanyang University
- Investigators
- Dae Won Jun, M.D., Ph.D., Study chair, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579158
- Sponsor's protocol ID
- HanyangU
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2022
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh JH, Yoon EL, Park H, Lee S, Jo AJ, Cho S, Kwon E, Nah EH, Lee JH, Park JH, Ahn SB, Jun DW. Efficacy and safety of time-restricted eating in metabolic dysfunction-associated steatotic liver disease. J Hepatol. 2025 Dec;83(6):1256-1265. doi: 10.1016/j.jhep.2025.06.005. Epub 2025 Jun 19.
PubMed 40543603
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05579158
- Acronym / sponsor ID
- HanyangU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- National Institute of Health, Korea
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 13 Oct 2022 (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.
In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) | Experimental | Behavioral: Mobile application and wearable device, Behavioral: Time-restricted eatingThis arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day). |
| Mobile application-supported calorie restriction (mCR) | Active comparator | Behavioral: Mobile application and wearable deviceThis arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of only calorie restriction (500kcal below estimated energy requirement). |
| Calorie restriction (CR) | No intervention | –Standard of care. This arm receives a brief counseling of calorie restriction. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 19 years who are willing and able to complete all procedures
- Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))
Key exclusion criteria (9 listed)
- Body mass index (BMI) <23
- Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
- Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
- Significant alcohol intake (>210g/week for men, >140g/week for women)
- Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure > 200/120 mmHg)
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 |
|---|---|---|
| Mobile application and wearable deviceMobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity | Behavioural | Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE), Mobile application-supported calorie restriction (mCR) |
| Time-restricted eatingTime-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day) | Behavioural | Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) |
Primary outcome
Change in hepatic steatosis (%)
Time frame: 16 weeks
Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
14 secondary outcomes
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk
Time frame: 16 weeks
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)
Time frame: 16 weeks
Change in body weight (kg)
Time frame: 16 weeks
Change in systolic blood pressure (mmHg)
Time frame: 16 weeks
Change in low-density lipoprotein level (mg/dL)
Time frame: 16 weeks
Change in serum alanine aminotransferase level (IU/L)
Time frame: 16 weeks
Change in hemoglobin A1c level (%)
Time frame: 16 weeks
Change in insulin sensitivity
Time frame: 16 weeks
Change in urine microalbumin (mcg/min)
Time frame: 16 weeks
Change in body muscle mass (kg)
Time frame: 16 weeks
Change in liver fibrosis by liver stiffness (kPa)
Time frame: 16 weeks
Change in liver steatosis by controlled attenuation parameter (dB/m)
Time frame: 16 weeks
Change in body weight (kg) at 6 months after the intervention
Time frame: 40 weeks
Change in body weight (kg) at 12 months after the intervention
Time frame: 64 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 24 Jan 2024.
- Derived from this study: PubMed 40543603Oh JH, Yoon EL, Park H, Lee S, Jo AJ, Cho S, Kwon E, Nah EH, Lee JH, Park JH, Ahn SB, Jun DW. Efficacy and safety of time-restricted eating in metabolic dysfunction-associated steatotic liver disease. J Hepatol. 2025 Dec;83(6):1256-1265. doi: 10.1016/j.jhep.2025.06.005. Epub 2025 Jun 19.
- 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.
Dae Won Jun, M.D., Ph.D. study chair
Hanyang 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 Mobile application and wearable device and Time-restricted eating in people with Non-Alcoholic Fatty Liver Disease and Time Restricted Feeding, run by Hanyang University at 1 site in South Korea.
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 9 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 24 Jan 2024. 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 South Korea. 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 hepatic steatosis (%) (time frame: 16 weeks). 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 NCT05579158, 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 24 Jan 2024.