Status:
UNKNOWN
Impact of Time-restricted Feeding in NAFLD
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
University of Turin, Italy
Conditions:
Fatty Liver Disease
Fatty Liver
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Patients will be trained according to the 10 rules of a healthy nutrition according to the German Ass...
Detailed Description
Patients are recruited in the Liver Outpatient Clinic of the University Medical Center of Mainz. About 100 patients will be enrolled in this pilot study. Inclusions criteria are exclusions of known c...
Eligibility Criteria
Inclusion
- Patients with steady medication during the last 3 months. A diabetes mellitus must not be decompensated (HbA1c \<6.5%). Patients with advanced fibrosis - defined about the non-invasive Fibroscan-procedure (Fibroscan \>13 kPa) - will not be included.
- Complete inclusion criteria:
- Age between 18 and 75 years
- Body Mass Index (BMI) \> 25 kg/m2
- Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
- Liver elastography \< 13 kPa
- Capability to understand the study and the individual consequences of participation
- Signed and dated declaration of agreement in the forefront of the study
- Complete exclusion criteria:
- Liver cirrhosis
- Hepatocellular carcinoma or non-curative treated carcinoma
- Alcohol consumption \>20g (female) und \>30 g (male)/day
- Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, 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)
- Changes in body weight \> 5% in the last 6 months
- Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
- Uncontrolled diabetes type 2 defined as HbA1c value \> 9.0% or insulin depending type 2 diabetes
- Pregnancy
- Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
- Patients after organ transplantations
- Missing or lacking consent capability
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05220956
Start Date
October 1 2021
End Date
December 1 2024
Last Update
December 28 2023
Active Locations (1)
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1
University Medical Center of the Johannes Gutenberg Univeristy
Mainz, Rhineland-Palatinate, Germany, 55131