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

Hanyang University

Status: Completed

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

Treatments: Behavioral: Mobile application and wearable device; Behavioral: Time-restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT05579158

HanyangU

Details and patient eligibility

About

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.

Enrollment: 337 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 3 patient groups

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

Experimental group

Description:

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).

Treatment:

Behavioral: Mobile application and wearable device

Behavioral: Time-restricted eating

Mobile application-supported calorie restriction (mCR)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Mobile application and wearable device

Calorie restriction (CR)

No Intervention group

Description:

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