Skip to main content
OpenTrials
Completed

NCT Number: NCT05579158

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Behavior Digestive System Diseases Fasting Fatty Liver Feeding Behavior Intermittent Fasting Liver Diseases Mobile Technology Time Restricted Feeding

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang University Seoul Hospital

Seoul, 133792, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application and wearable device

Behavioral

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

Time-restricted eating

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 16 weeks

    Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)

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

    Time frame: 16 weeks

    Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver

  3. Change in body weight (kg)

    Time frame: 16 weeks

    Evaluate the mean change in body weight (kg)

  4. Change in systolic blood pressure (mmHg)

    Time frame: 16 weeks

    Evaluate the mean change in systolic blood pressure (mmHg)

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

    Time frame: 16 weeks

    Evaluate the mean change in low-density lipoprotein level (mg/dL)

  6. Change in serum alanine aminotransferase level (IU/L)

    Time frame: 16 weeks

    Evaluate the mean change in serum alanine aminotransferase level (IU/L)

  7. Change in hemoglobin A1c level (%)

    Time frame: 16 weeks

    Evaluate the mean change in hemoglobin A1c level (%)

  8. Change in insulin sensitivity

    Time frame: 16 weeks

    Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)

  9. Change in urine microalbumin (mcg/min)

    Time frame: 16 weeks

    Evaluate the mean change in urine microalbumin (mcg/min)

  10. Change in body muscle mass (kg)

    Time frame: 16 weeks

    Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)

  11. Change in liver fibrosis by liver stiffness (kPa)

    Time frame: 16 weeks

    Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®

  12. Change in liver steatosis by controlled attenuation parameter (dB/m)

    Time frame: 16 weeks

    Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®

  13. Change in body weight (kg) at 6 months after the intervention

    Time frame: 40 weeks

    Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period

  14. Change in body weight (kg) at 12 months after the intervention

    Time frame: 64 weeks

    Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Collaborators

  • National Institute of Health, Korea

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.