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

Last updated: January 22, 2024
Sponsor: Hanyang University
Overall Status: Completed

Phase

N/A

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Mobile application and wearable device

Time-restricted eating

Clinical Study ID

NCT05579158
HanyangU
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥ 19 years who are willing and able to complete all procedures
  • Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonanceimaging, and controlled attenuation parameter (≥260 dB/m))

Exclusion

Exclusion Criteria:

  • Body mass index (BMI) <23
  • Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chroniccholestatic liver disease
  • Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen,systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, andstatin (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 atrioventricularblock, 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

Study Design

Total Participants: 337
Treatment Group(s): 2
Primary Treatment: Mobile application and wearable device
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
January 12, 2024

Connect with a study center

  • Hanyang University Seoul Hospital

    Seoul, 133792
    Korea, Republic of

    Site Not Available

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