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Muscle-Building amino acids tested in liver disease patients

NCT ID NCT06121492

Disease control Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking branched-chain amino acid (BCAA) supplements for 24 weeks can help people with liver cirrhosis who have low muscle mass (sarcopenia) regain muscle and improve strength. About 86 adults aged 18–85 will be randomly assigned to receive either BCAA or a placebo twice daily, along with diet and exercise advice. The main goal is to see if more people in the BCAA group recover from sarcopenia compared to the placebo group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 85 years. * Patients who have been diagnosed with liver cirrhosis due to any etiology. * Patients with sarcopenia as determined by a computed tomography scan within the last 3 months. For males, sarcopenia is defined as a Skeletal Muscle Index (SMI) less than 42 cm²/m², and for females, an SMI less than 38 cm²/m² Exclusion Criteria: * Patients with hepatocellular carcinoma outside the Milan criteria. * Patients with Overt Hepatic Encephalopathy or gastrointestinal bleeding within the last 6 months. * Patients with refractory ascites (ascites that does not respond to treatment). * Patients in the advanced stage of cirrhosis with Child-Turcotte-Pugh (CTP) score C. * Patients with acute-on-chronic liver failure (ACLF). * Patients with uncontrollable decompensated comorbidities, including chronic heart failure classified as NYHA 3-4, patients with kidney disease requiring dialysis, patients with severe obstructive lung disease classified as Gold D, patients with other non-liver cancers requiring chemotherapy, and patients with chronic infections such as tuberculosis. * Patients who have previously undergone liver or kidney transplantation. * Patients with Human Immunodeficiency Virus (HIV) infection. * Pregnant or breastfeeding patients.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis of the liver Sarcopenia

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

    Bangkok, Bangkok, 10700, Thailand

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