RE and Probiotics in MAFLD/NAFLD

ConditionsNASHNAFLDMAFLD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNicolaus Copernicus University

About this trial

This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD/NAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.

Eligibility criteria

Qualifiers

Diagnosis of NAFLD/MAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)

Age 18-60 years

Ability to understand the study procedures and provide informed consent.

Stable clinical condition for at least 3 months prior to study initiation.

Disqualifiers

Lack of fluency in English or Polish

Significant (structural) limitation of upper and/or lower limb mobility

Pregnancy or breastfeeding

Inability to understand instructions

Trial design

Treatments tested in this trial

  • physical exercise programme
  • probiotics supplementation
  • Placebo

Treatment groups

180 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Nicolaus Copernicus University

Lead sponsor

University of Oxford

Collaborator

Medical University of Warsaw

Collaborator