- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06506513
Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease (MYO-MASLD)
July 10, 2026 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Targeting Myosteatosis Though Physical Exercise to Treat Metabolic Dysfunction-associated Steatotic Liver Disease
Muscle changes including myosteatosis are reported as highly prevalent in metabolic dysfunction-associated steatotic liver disease (MASLD).
Recent studies highlighted a link between muscle fat content and liver disease severity.
Conversely, MASLD histological remission though diet or metabolic surgeries is also linked to a decrease in muscle fat content.
Therefore, skeletal muscle appears as a potential target to treat MASLD.
Study Overview
Status
Recruiting
Detailed Description
In this monocenter interventional study, we will assess the impact of physical activity on muscle fat content and liver disease severity in MASLD as well as the mechanisms mediating the potential beneficial effects of exercise.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillaume Henin, MD, PhD student
- Phone Number: 0032494312548
- Email: guillaume.henin@uclouvain.be
Study Contact Backup
- Name: Nicolas Lanthier, MD, PhD
- Phone Number: 003227647089
- Email: nicolas.lanthier@saintluc.uclouvain.be
Study Locations
-
-
-
Brussels, Belgium, 1200
- Recruiting
- Cliniques universitaires Saint-Luc
-
Contact:
- Guillaume Henin, MD, PhD student
- Phone Number: 0032494312548
- Email: guillaume.henin@uclouvain.be
-
Contact:
- Nicolas Lanthier, MD, PhD
- Phone Number: 003227647089
- Email: nicolas.lanthier@saintluc.uclouvain.be
-
Principal Investigator:
- Nicolas Lanthier, MD, PhD
-
Sub-Investigator:
- Audrey Loumaye, MD, PhD
-
Louvain-la-Neuve, Belgium, 1348
- Recruiting
- Centre d'investigation clinique en nutrition
-
Contact:
- Guillaume Henin, MD, PhD student
-
Contact:
- louise Deldicque, PhD
- Email: louise.deldicque@uclouvain.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- confirmed MASLD at abdominal imaging
- confirmed excessive muscle lipid content at imaging
- stable weight
Exclusion Criteria:
- severe comorbidities including active malignancies, neuromuscular degenerative diseases
- contraindications to physical activity
- excessive alcohol consumption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
in this control group, patients will perform non-cardiovascular non-intensity training (stretching, meditation).
|
Low intensity exercise training
|
|
Active Comparator: moderate-intensity low interval training group
In this group, patients will perform moderate-intensity low interval training.
|
Moderate intensity exercise training
|
|
Active Comparator: high-intensity interval training
In this group, patients willp erform high-intensity interval training.
|
High-intensity interval training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the impact of physical activity on muscle and liver phenotypes
Time Frame: every four weeks from baseline till study completion
|
the investigators will assess at baseline and every four weeks till study completion the impact of intervention on liver phenotype assessed by transient elastography and muscle phenotype assessed by MRI
|
every four weeks from baseline till study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicolas Lanthier, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Henin G, Loumaye A, Leclercq IA, Lanthier N. Myosteatosis: Diagnosis, pathophysiology and consequences in metabolic dysfunction-associated steatotic liver disease. JHEP Rep. 2023 Nov 14;6(2):100963. doi: 10.1016/j.jhepr.2023.100963. eCollection 2024 Feb.
- Henin G, Loumaye A, Deldicque L, Leclercq IA, Lanthier N. Unlocking liver health: Can tackling myosteatosis spark remission in metabolic dysfunction-associated steatotic liver disease? Liver Int. 2024 Aug;44(8):1781-1796. doi: 10.1111/liv.15938. Epub 2024 Apr 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
June 27, 2024
First Submitted That Met QC Criteria
July 11, 2024
First Posted (Actual)
July 17, 2024
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST-IR-01 MYO-MASLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.