NCT05309642Completed
Nonalcoholic Fatty Liver Disease - Intermittent Calorie Restriction (FLICR) Study
Effect of 12-week Intermittent Calorie Restriction on Liver Fat Content in Comparison With Standard-of-care in Patients With Nonalcoholic Fatty Liver Disease: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Feb 2024
Brief summary (registry, in English)
Several diets have been proposed to reduce liver steatosis in patients with nonalcoholic fatty liver disease (NAFLD), and various effects on liver steatosis have been observed. The objective of this trial is to compare the effects of intermittent calorie restriction (ICR) (5:2 diet) and standard-of-care (SoC) on reduction of hepatic steatosis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 12 Mar 2022
- Start date
- 7 Mar 2022
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05309642
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 7 Mar 2022 to the primary completion date, 6 Dec 2023
- 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, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, drug induced liver injury, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
- Medications which cause liver disease or secondary NAFLD (e.g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
- Diabetes
Other
- Daily alcohol consumption \>30 g in men and \>20 g in women
- Liver cirrhosis
- Hepatocellular carcinoma
- Changes in body weight \> 5% in the last 3 months
- Intake of medical treatment for NAFLD/NASH in the last 6 months (except for vitamin E)
- Pregnancy
- Patients after organ transplantations
- Missing or lacking consent capability
Who the study is looking for
- NAFLD diagnosed by (1) Histologic assessment with a fat accumulation of more than 5% of the liver's weight in a biopsy, or (2) Radiologic assessment with a MRI-PDFF ≥8%.
- Age between 19 and 75 years
- Capability to understand the study and the individual consequences of participation
- Signed and dated declaration of agreement in the forefront of the study
Age in the registry: 19 years to 75 years · Sex: All · Does not accept 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 |
|---|---|---|---|
| Ewha Womans University College of Medicine 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.