Effects of Time-Restricted Feeding on Non-Alcoholic Fatty Liver Disease

Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD

This study is testing if eating only during an 8-hour window can help people with Non-Alcoholic Fatty Liver Disease improve their liver health and overall metabolism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Johannes Gutenberg University Mainz (Academic / other)
• Drugs / interventions: Methotrexate
• Locations: 1 site (Mainz, Rheinland-Pfalz)
• Trial ID: NCT05220956 on ClinicalTrials.gov

What this trial studies

This randomized controlled study investigates the impact of Time-Restricted Feeding (TRF) on patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Participants will be trained in healthy nutrition and then randomly assigned to either a TRF group, which will eat within an 8-hour window, or a control group with no eating time restrictions. The study aims to assess improvements in insulin sensitivity, metabolic inflammation, and liver fat reduction over a 12-week intervention period. Patients will undergo multiple assessments, including liver stiffness measurements, throughout the study duration of 24 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a BMI over 25 and diagnosed with grade 3 liver steatosis but without advanced fibrosis.

Not a fit: Patients with advanced liver fibrosis, liver cirrhosis, or other chronic liver diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel dietary intervention to improve liver health and metabolic outcomes in patients with NAFLD.

How similar studies have performed: Other studies have shown promising results with time-restricted feeding in various metabolic conditions, suggesting potential for success in this novel application.

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

Where this trial is running

Mainz, Rheinland-Pfalz

• University Medical Center of the Johannes Gutenberg Univeristy — Mainz, Rheinland-Pfalz, Germany (Recruiting)

Study contacts

• Principal investigator: Jörn M. Schattenberg, Prof. — 1. Medical Department
• Study coordinator: Jörn M. Schattenberg, Prof.

Conditions Fatty Liver Disease; Fatty Liver; Fatty Liver, Nonalcoholic; liver fibrosis; time restricted feeding