Oral Branched-chain Amino Acid Supplementation for Cirrhotic Patients With Sarcopenia

NCT06121492 | Enrolling By Invitation Phase 3

• 1 other identifier: SI 655/2023
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Sarcopenia; Cirrhosis of the Liver

Keywords

sarcopenia; cirrhosis; Branched-chain amino acids; nutrition

Outcome Measures

Primary Outcomes (1)

• Resolution of sarcopenia

  To study the differences in the proportions of patients with resolution from sarcopenia measured by abdominal computed tomography at 24 weeks among cirrhotic patients with sarcopenia who received BCAA supplementation and the placebo group for 24 weeks. Resolution of sarcopenia implies better nutritional status and prognosis.

  24 weeks

Secondary Outcomes (10)

• change of skeletal muscle index (SMI) measured by abdominal computed tomography (CT)

  24 weeks

• change of appendicular skeletal muscle mass (ASM)

  24 weeks

• change of index of appendicular skeletal muscle mass (ASM, kg) divided by height squared (meter^2)

  24 weeks

• change of handgrip

  24 weeks

• change of 6-meter walk speed

  24 weeks

Study Arms (2)

Branched-chain amino acid

EXPERIMENTAL

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.

Drug: Branched-chain amino acid

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Branched-chain amino acid DRUG

In the 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.

Also known as: BCAA

Branched-chain amino acid

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (22)

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MeSH Terms

Conditions

Sarcopenia; Fibrosis

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Phunchai Charatcharoenwitthaya, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All of participants, care providers, investigators and outcome assessors will be blinded. Only a research nurse will know which arm the participants are assigned to. The packages of BCAA and placebo are identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The participants will be randomly and blindly divided into two groups: (branched-chain amino acids) BCAA group and the placebo group, using a 1:1 ratio, with each group consisting of 43 individuals. The blinded participants will take either BCAA or placebo for 24 weeks.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 8, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)