Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

NCT ID: NCT05579158

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-01-12

Brief 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. 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Time Restricted Feeding; Mobile Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)

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).

Group Type: EXPERIMENTAL

Mobile application and wearable device

Intervention Type: BEHAVIORAL

Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity

Time-restricted eating

Intervention Type: BEHAVIORAL

Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)

Mobile application-supported calorie restriction (mCR)

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).

Group Type: ACTIVE_COMPARATOR

Mobile application and wearable device

Intervention Type: BEHAVIORAL

Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity

Calorie restriction (CR)

Standard of care. This arm receives a brief counseling of calorie restriction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile application and wearable device

Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity

Intervention Type: BEHAVIORAL

Time-restricted eating

Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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))

Exclusion Criteria

• 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
• Diagnosed with diabetes on medication or insulin
• Participation in a weight-loss program within 12 weeks
• MRI contraindications

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Health, Korea

OTHER_GOV

Sponsor Role: collaborator

Hanyang University

OTHER

Sponsor Role: lead

Responsible Party

Dae Won Jun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dae Won Jun, M.D., Ph.D.

Role: STUDY_CHAIR

Hanyang University

Locations

Hanyang University Seoul Hospital

Seoul, , South Korea

Countries

South Korea

References

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 Jun 19:S0168-8278(25)02272-X. doi: 10.1016/j.jhep.2025.06.005. Online ahead of print.

Reference Type: DERIVED

PMID: 40543603 (View on PubMed)

Other Identifiers

HanyangU

Identifier Type: -

Identifier Source: org_study_id