Metabolic Dysfunction-associated Steatotic Liver DiseaseMYO-MASLDNCT06506513
Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease
A study testing High-intensity interval training, Moderate intensity exercise training and Low intensity exercise training in people with Metabolic Dysfunction-associated Steatotic Liver Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- High-intensity interval training, Moderate intensity exercise training and Low intensity exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2025to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- confirmed MASLD at abdominal imaging
- confirmed excessive muscle lipid content at imaging
- stable weight
Who cannot join
- severe comorbidities including active malignancies, neuromuscular degenerative diseases
- contraindications to physical activity
- excessive alcohol consumption
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Guillaume Henin, MD, PhD student, 0032494312548, guillaume.henin@uclouvain.be
Nicolas Lanthier, MD, PhD, 003227647089, nicolas.lanthier@saintluc.uclouvain.be
- Recruiting
Centre d'investigation clinique en nutrition
Louvain-la-Neuve, 1348
Guillaume Henin, MD, PhD student
louise Deldicque, PhD, louise.deldicque@uclouvain.be
About this study
Official title: 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.
Read the 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.
- Being tested
- High-intensity interval training, Moderate intensity exercise training, Low intensity exercise training
- Keywords
- metabolic dysfunction-associated steatotic liver disease, MASLD, physical activity, myosteatosis, magnetic resonance imaging, magnetic resonance specroscopy, muscle biopsy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
High-intensity interval training
Moderate intensity exercise trainingOther
Moderate intensity exercise training
Low intensity exercise trainingOther
Low intensity exercise training
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | in this control group, patients will perform non-cardiovascular non-intensity training (stretching, meditation). Receives: Other: Low intensity exercise training |
| moderate-intensity low interval training group | Active comparator | In this group, patients will perform moderate-intensity low interval training. Receives: Other: Moderate intensity exercise training |
| high-intensity interval training | Active comparator | In this group, patients willp erform high-intensity interval training. Receives: Other: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of physical activity on muscle and liver phenotypes
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
Measured: every four weeks from baseline till study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients presenting both MASLD and an excessive muscle lipid content (myosteatosis) assessed by magnetic resonance imaging will be recruited. All patients will then be randomized in three groups corresponding to three physical activity programs of increasing intensity.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Concerted Research Action, Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Nicolas Lanthier, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506513
- Sponsor's protocol ID
- ST-IR-01 MYO-MASLD
- Acronym
- MYO-MASLD
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38322420Henin 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.
PubMed 38623714