Impact of Time-restricted Feeding in NAFLD

NCT05220956 | Unknown

• 1 other identifier: 21-00784
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fatty Liver Disease; Fatty Liver; Fatty Liver, Nonalcoholic

Keywords

liver fibrosis; time restricted feeding

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of TRF on liver steatosis by CAP (dB/m)

  The primary outcome of interest is a change in CAP value of a least 20 db/m with TRF

  12 weeks

Secondary Outcomes (9)

• Changes in liver fibrosis by liver stiffness (kPa) under TRF

  12 weeks

• Changes in FIB-4 as indirect non-invasive tools of liver fibrosis

  12 weeks

• Evaluation of changes in direct non-invasive tool of liver fibrosis ELF

  12 weeks

• Evaluation of changes in direct marker of liver fibrogenesis PRO-C3 (ng/ml)

  12 weeks

• Evaluation of changes in liver-specific quality of life

  12 weeks

Study Arms (2)

Intermittent fasting

OTHER

This arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks.

Behavioral: Intermittent fasting

DGE diet

OTHER

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.

Behavioral: DGE diet

Interventions

Intermittent fasting BEHAVIORAL

One arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE.

Also known as: Time restricted feeding

Intermittent fasting

DGE diet BEHAVIORAL

The control arm is not a subject to any time restrictions concerning eating while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE.

DGE diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Body Mass Index (BMI) \> 25 kg/m2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• University of Turin, Italy: collaborator

Study Sites (1)

University Medical Center of the Johannes Gutenberg Univeristy

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis; Intermittent Fasting

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Jörn M. Schattenberg, Prof.

  1. Medical Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörn M. Schattenberg, Prof.

CONTACT

06131-17; joern.schattenberg@unimedizin-mainz.de

Belinda Schröder

CONTACT

06131-17; belinda.schroeder@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Jörn M. Schattenberg

Model Details: This is a randomised controlled study with NAFLD-patients. One arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: February 2, 2022
• Study Start: October 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)