NCT05579158Completed
Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 337 (actual)
- First submitted
- 10 Oct 2022
- Start date
- 1 Feb 2023
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Hanyang University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05579158
What you commit to
- Study type: Interventional
- Participants enrolled: 337
- From 1 Feb 2023 to the primary completion date, 12 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- 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
Other
- Body mass index (BMI) \<23
- Significant alcohol intake (\>210g/week for men, \>140g/week for women)
- Participation in a weight-loss program within 12 weeks
- MRI contraindications
Who the study is looking for
- 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))
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.