Impact of Time-restricted Feeding in NAFLD

Launched by JOHANNES GUTENBERG UNIVERSITY MAINZ · Jan 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Time-Restricted Feeding (TRF) on patients with Non-Alcoholic Fatty Liver Disease (NAFLD). In simple terms, this means that some participants will eat their meals within a specific time window each day for 12 weeks, while others will follow their usual eating patterns without restrictions. The researchers want to find out if this way of eating can help improve insulin sensitivity, reduce inflammation, and lower fat in the liver.

To be eligible for this study, participants must be between 18 and 75 years old, have a body mass index (BMI) over 25, and have a certain degree of liver fat. They should also have stable medications for the last three months and not have advanced liver damage. During the trial, participants will receive guidance on healthy eating practices, and they will be monitored throughout the study to see how their health changes. It’s essential for potential participants to understand the study and give their consent before joining.

Gender

ALL

Eligibility criteria

• • 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:
• • 1. Age between 18 and 75 years
• • 2. Body Mass Index (BMI) \> 25 kg/m2
• • 3. Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
• • 4. Liver elastography \< 13 kPa
• • 5. Capability to understand the study and the individual consequences of participation
• • 6. Signed and dated declaration of agreement in the forefront of the study
• Complete exclusion criteria:
• • 1. Liver cirrhosis
• • 2. Hepatocellular carcinoma or non-curative treated carcinoma
• • 3. Alcohol consumption \>20g (female) und \>30 g (male)/day
• • 4. 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
• • 5. Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
• • 6. Changes in body weight \> 5% in the last 6 months
• • 7. Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
• • 8. Uncontrolled diabetes type 2 defined as HbA1c value \> 9.0% or insulin depending type 2 diabetes
• • 9. Pregnancy
• • 10. Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
• • 11. Patients after organ transplantations
• • 12. Missing or lacking consent capability