RE and Probiotics in MAFLD/NAFLD

NCT06563921 | Not Yet Recruiting

• 1 other identifier: MAFLD_NAFLD_probiotics_RE
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

NASH; MAFLD; NAFLD; Probiotics; Resistance training; Gut microbiota; Hypertrophy training

Outcome Measures

Primary Outcomes (1)

• Change in liver fat measured using MRI

  12 weeks

Secondary Outcomes (8)

• changes in weight in kilograms using scale

  12 weeks

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

  12 weeks

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

  12 weeks

• changes in visceral fat level measured using bioelectrical impedance method

  12 weeks

• HDL cholesterol concentration measured in mg/dL (or mmol/L) using a standardized direct enzymatic assay from fasting venous blood samples

  12 weeks

Other Outcomes (5)

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

  12 weeks

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

  12 weeks

• changes in RMR measured using CPET

  12 weeks

Study Arms (4)

Experimental: probiotics supplementation + physical exercise program

EXPERIMENTAL

Behavioral: physical exercise program in the form of a resistance/hypertrophy-oriented resistance program Dietary Supplement: probiotics supplementation

Behavioral: physical exercise programme; Dietary Supplement: probiotics supplementation

Active Comparator: placebo + resistance/hypertrophy-oriented resistance program plus placebo

ACTIVE COMPARATOR

placebo + resistance/hypertrophy-oriented resistance program

Behavioral: physical exercise programme; Dietary Supplement: Placebo

probiotics supplementation

EXPERIMENTAL

Dietary Supplement: probiotics supplementation

Dietary Supplement: probiotics supplementation

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

physical exercise programme BEHAVIORAL

resistance/hypertrophy-oriented resistance programme

Active Comparator: placebo + resistance/hypertrophy-oriented resistance program plus placebo; Experimental: probiotics supplementation + physical exercise program

Placebo DIETARY_SUPPLEMENT

Placebo

Active Comparator: placebo + resistance/hypertrophy-oriented resistance program plus placebo; placebo

probiotics supplementation DIETARY_SUPPLEMENT

probiotics supplementation

Experimental: probiotics supplementation + physical exercise program; probiotics supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Lack of fluency in English or Polish
• Significant (structural) limitation of upper and/or lower limb mobility
• Pregnancy or breastfeeding
• Inability to understand instructions
• Shift work
• Participation in any study or research project within the last 3 months
• Participation in an interventional drug study within the last 3 months
• Participants with hepatic steatosis and regular alcohol consumption \> 30 g/day
• Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic/genetic diseases (e.g., Wilson's disease))
• Anticoagulant/antiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \< 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment
• Use of medications such as steroids, methotrexate, metformin
• Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)
• Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \[e.g., cervical\] or benign skin cancer), unless complete remission has been achieved
• Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment
• Known allergy to probiotics

Sponsors & Collaborators

• Medical University of Warsaw: collaborator
• Nicolaus Copernicus University: lead
• University of Oxford: collaborator

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Lynette Hodges, PhD

  Massey University, New Zealand

  STUDY CHAIR

• Beata Januszko-Giergielewicz, Assoc. Prof.

  Nicolaus Copernicus University, Poland

  STUDY CHAIR

• Maciej Słupski, Prof.

  Nicolaus Copernicus University, Poland

  STUDY CHAIR

• Karolina Skonieczna-Żydecka, Prof.

  Pomeranian Medical University in Szczecin, Poland

  STUDY CHAIR

• Agnieszka Cudnoch-Jędrzejewska, Prof.

  Warsaw Medical University, Poland

  STUDY CHAIR

• Sławomir Kujawski, PhD

  Nicolaus Copernicus University, Poland

  STUDY DIRECTOR

• Joanna Słomko, Prof.

  Nicolaus Copernicus University, Poland

  STUDY CHAIR

• Karl J. Morten, Prof.

  Oxford University, UK

  STUDY CHAIR

• Hanna Tabisz, MSc

  Nicolaus Copernicus University, Poland

  STUDY CHAIR

• Magdalena Krintus, prof

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Sławomir Manysiak, PhD

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Aleksandra Modlińska

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Przemysław Ratajczak, MD

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Agnieszka Radzimińska

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Wojciech Kazimierczak

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

• Elżbieta Zawada

  Nicolaus Copernicus Univeristy

  STUDY CHAIR

Central Study Contacts

Sławomir Kujawski, PhD

CONTACT

0048791448117; skujawski@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 21, 2024
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2031
• Study Completion (Estimated): April 10, 2036
• Last Updated: April 9, 2026

Record last verified: 2026-04