Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • physical exercise programme

    Behavioral

    resistance/hypertrophy-oriented resistance programme

  • probiotics supplementation

    Dietary supplement

    probiotics supplementation

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: Experimental: probiotics supplementation + physical exercise programExperimental treatment 2 interventions
Group B: Active Comparator: placebo + resistance/hypertrophy-oriented resistance program plus placeboActive comparator 2 interventions
Group C: probiotics supplementationExperimental treatment 1 intervention
Group D: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in liver fat measured using MRI

Time frame
12 weeks

Secondary outcomes

1

changes in weight in kilograms using scale

Time frame
12 weeks
2

changes in body fat mass in kilograms measured using bioelectrical impedance method

Time frame
12 weeks
3

changes in free-fat mass in kilograms measured using bioelectrical impedance method

Time frame
12 weeks
4

changes in visceral fat level measured using bioelectrical impedance method

Time frame
12 weeks

Other outcomes

1

autonomic nervous system function indicated by LF/HF ratio in supine position measured using Task Force Monitor

Time frame
12 weeks
2

Changes in maximal strength, operationalized as the heaviest load lifted for exactly 10 repetitions (10RM) on calibrated resistance machines

Time frame
12 weeks
3

changes in RMR measured using CPET

Time frame
12 weeks
4

changes in the dynamics of blood glucose level in response to standardized breakfast intake using continuous glucose monitoring

Time frame
12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicolaus Copernicus University

Lead sponsor

University of Oxford

Collaborator

Medical University of Warsaw

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: