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

NCT05579158 | Completed

• 1 other identifier: HanyangU
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in hepatic steatosis (%)

  Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver

  16 weeks

Secondary Outcomes (14)

• Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk

  16 weeks

• Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)

  16 weeks

• Change in body weight (kg)

  16 weeks

• Change in systolic blood pressure (mmHg)

  16 weeks

• Change in low-density lipoprotein level (mg/dL)

  16 weeks

Study Arms (3)

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).

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).

Behavioral: Mobile application and wearable device

Calorie restriction (CR)

NO INTERVENTION

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

Interventions

Mobile application and wearable device BEHAVIORAL

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

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

Time-restricted eating BEHAVIORAL

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

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead
• National Institute of Health, Korea: collaborator

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, 133792, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40543603 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Intermittent Fasting

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Dae Won Jun, M.D., Ph.D.

  Hanyang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: February 1, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)