Oral Branched-chain Amino Acid Supplementation for Cirrhotic Patients With Sarcopenia
Key facts
- Who runs it
- Mahidol University
- Where
- Bangkok, ThailandSee the site
- Trial code
- Status
- Enrolling by invitation
- Phase
- Phase 3
- People taking part
- 86 people, planned
- Started
- 15 Nov 2023
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Branched-chain amino acid
- Placebo
- Record updated
- 29 September 2025
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Patients who have previously undergone liver or kidney transplantation
- Patients with Overt Hepatic Encephalopathy or gastrointestinal bleeding within the last 6 months
- 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 with Human Immunodeficiency Virus (HIV) infection
- Patients with hepatocellular carcinoma outside the Milan criteria
- 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
- Pregnant or breastfeeding patients
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in Thailand
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandBangkok, ThailandNo longer taking part
About the trial
What the trial wants to find out
The goal of this clinical trial is to compare the nutritional parameters after 24-week supplementation of branched-chain amino acids in cirrhotic patients with low muscle mass.
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The main questions it aims to answer are:
Is there the differences in the proportions of cirrhotic patients recovering from low muscle mass at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group? Is there the differences in the change of skeletal muscle index (SMI) measured by abdominal computed tomography (CT) at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group? Is there changes in other indices related to low muscle mass, including appendicular skeletal muscle mass (ASM), ASM/height\^2, handgrip strength, and 6-meter walk speed at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group? Is there changes in the liver frailty index (LFI), consisting of handgrip strength, chair stands, and balance, at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group? Is there changes in serum albumin levels, at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group? Is there changes in severity of liver disease, including the Model for End-Stage Liver Disease-Sodium Score (MELD-Na score), Child-Turcotte-Pugh score, and liver stiffness measured by transient elastography at 24 weeks among cirrhotic patients with low muscle mass who received BCAA supplementation and the placebo group?
Participants will be asked to do following tasks:
Participants will be asked for basic information such as age, place of residence, and contact phone number.
Participants will undergo measurements of body weight, height, body mass index (BMI), muscle mass, and body fat content using a body composition analyzer, a total of 2 times (at the beginning and end of the research), and an upper abdominal computed tomography (CT) scan without additional radiation exposure, only once (at the end of the research) throughout the study.
Participants will be tested for muscle function, including handgrip strength, a 6-meter walk test, chair stands, and balance, all performed twice (at the beginning and end of the research).
Laboratory testing will include a complete blood count, liver and kidney function, blood clotting function, mineral levels, cholesterol, and glucose. Blood will be drawn a total of 2 times (at the beginning and end of the research) during the study, with each blood draw approximately 15 milliliters (1 tablespoon).
Transient elastography will be performed twice (at the beginning and end of the research) during the study, with each Transient elastography taking approximately 10 minutes.
Participants will be randomly assigned to either the group receiving branched chain amino acid (BCAA) medication or the placebo group, and you will take the assigned medication twice daily for a total of 24 weeks.
Participants will receive dietary and exercise recommendations from the research team and nutritionists in a group format, taking approximately 1 hour.
Participants will have follow-up appointments to monitor your condition three times during the study, at weeks 4, 12, and 24. These appointments will include inquiries about side effects from medication and placebo use, exercise, and dietary intake, each lasting approximately 30 minutes.
Participants will be asked to take photos of your daily meals for 3 days before meeting with the physician at weeks 4 and 12, to provide data for assessing your calorie intake. Participants can send these meal images via the online application, prepared by our research team. If participants are unable to do so, participants will be asked to keep a food diary and report your food and portion sizes to the research team.
The 2 groups in the trial
- Branched-chain amino acidTreatment being tested
In the branched-chain amino acid (BCAA group), participants will receive oral BCAA for 24 weeks, with a daily dosage of approximately 13.68 g/day. Each sachet of BCAA will contain 6.84 g of BCAA (valine 1.82 g, leucine 3.29 g, isoleucine 1.72 g), total protein 17.08 g, carbohydrates 25.48 g, fat 5.66 g, providing 221.2 kcal of energy. Each sachet weighs 52 g and should be mixed with 150 ml of water. Participants will consume 2 sachets daily, one after breakfast and one after dinner.
- PlaceboPlacebo, for comparison
In the placebo group, BCAA will be replaced with maltodextrin. Each sachet of the placebo will contain a total of 5.93 g of protein, 35.87 g of carbohydrates, 6.00 g of fat, providing 221.2 kcal of energy. Like the BCAA sachets, each placebo sachet will weigh 52 g and should be mixed with 150 ml of water. Participants in the placebo group will consume 2 sachets daily, one after breakfast and one after dinner.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Oral Branched-chain Amino Acid Supplementation for Cirrhotic Patients With Sarcopenia: a Double-blinded Randomized Controlled Trial
- Fit questions
- Built from NCT06121492, who can take part
- Record updated
- 29 September 2025