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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579158
• Other study ID #: HanyangU
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Mobile Technology
• Non-Alcoholic Fatty Liver Disease
• Time Restricted Feeding

Intervention

Behavioral:
• Mobile application and wearable device
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
• Time-restricted eating
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	National Institute of Health, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic steatosis (%)	Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver	16 weeks
Secondary	Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk	Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)	16 weeks
Secondary	Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)	Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver	16 weeks
Secondary	Change in body weight (kg)	Evaluate the mean change in body weight (kg)	16 weeks
Secondary	Change in systolic blood pressure (mmHg)	Evaluate the mean change in systolic blood pressure (mmHg)	16 weeks
Secondary	Change in low-density lipoprotein level (mg/dL)	Evaluate the mean change in low-density lipoprotein level (mg/dL)	16 weeks
Secondary	Change in serum alanine aminotransferase level (IU/L)	Evaluate the mean change in serum alanine aminotransferase level (IU/L)	16 weeks
Secondary	Change in hemoglobin A1c level (%)	Evaluate the mean change in hemoglobin A1c level (%)	16 weeks
Secondary	Change in insulin sensitivity	Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)	16 weeks
Secondary	Change in urine microalbumin (mcg/min)	Evaluate the mean change in urine microalbumin (mcg/min)	16 weeks
Secondary	Change in body muscle mass (kg)	Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)	16 weeks
Secondary	Change in liver fibrosis by liver stiffness (kPa)	Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®	16 weeks
Secondary	Change in liver steatosis by controlled attenuation parameter (dB/m)	Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®	16 weeks
Secondary	Change in body weight (kg) at 6 months after the intervention	Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period	40 weeks
Secondary	Change in body weight (kg) at 12 months after the intervention	Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period	64 weeks