Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 Association for Nutrition (DGE). One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. The control arm is not subject to any time restrictions concerning eating. It will be investigated whether TRF improves insulin sensitivity, impacts on metabolic inflammation and reduces liver steatosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Medical Center of the Johannes Gutenberg Univeristy
RECRUITING
Mainz
Contact Information
Primary
Jörn M. Schattenberg, Prof.
joern.schattenberg@unimedizin-mainz.de
06131-17
Backup
Belinda Schröder
belinda.schroeder@unimedizin-mainz.de
06131-17
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 100
Treatments
Other: Intermittent fasting
This arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks.
Other: DGE diet
This control arm is not a subject to any time restrictions concerning eating, solely patients will be trained according to the 10 rules of healthy nutrition of the DGE.
Related Therapeutic Areas
Sponsors
Leads: Johannes Gutenberg University Mainz
Collaborators: University of Turin, Italy

This content was sourced from clinicaltrials.gov