RE and Probiotics in MAFLD/NAFLD

Summary

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.

Conditions

• NASH
• NAFLD
• MAFLD

Interventions

BEHAVIORAL

physical exercise programme

resistance/hypertrophy-oriented resistance programme

DIETARY_SUPPLEMENT

probiotics supplementation

probiotics supplementation

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• Nicolaus Copernicus University

  lead OTHER

Principal Investigators

• Lynette Hodges, PhD · Massey University, New Zealand

• Beata Januszko-Giergielewicz, Assoc. Prof. · Nicolaus Copernicus University, Poland

• Maciej Słupski, Prof. · Nicolaus Copernicus University, Poland

• Karolina Skonieczna-Żydecka, Prof. · Pomeranian Medical University in Szczecin, Poland

• Agnieszka Cudnoch-Jędrzejewska, Prof. · Warsaw Medical University, Poland

• Sławomir Kujawski, PhD · Nicolaus Copernicus University, Poland

• Joanna Słomko, Prof. · Nicolaus Copernicus University, Poland

• Karl J. Morten, Prof. · Oxford University, UK

• Hanna Tabisz, MSc · Nicolaus Copernicus University, Poland

• Magdalena Krintus, prof · Nicolaus Copernicus Univeristy

• Sławomir Manysiak, PhD · Nicolaus Copernicus Univeristy

• Aleksandra Modlińska · Nicolaus Copernicus Univeristy

• Przemysław Ratajczak, MD · Nicolaus Copernicus Univeristy

• Agnieszka Radzimińska · Nicolaus Copernicus Univeristy

• Wojciech Kazimierczak · Nicolaus Copernicus Univeristy

• Elżbieta Zawada · Nicolaus Copernicus Univeristy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-10

Primary Completion

2031-04-10

Completion

2036-04-10