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

M

Mahidol University

Status and phase

Invitation-only
Phase 3

Conditions

Cirrhosis of the Liver
Sarcopenia

Treatments

Drug: Branched-chain amino acid
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06121492
SI 655/2023

Details and patient eligibility

About

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 a lower 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.

Full description

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 a lower 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.

Enrollment

86 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

86 participants in 2 patient groups, including a placebo group

Branched-chain amino acid
Experimental group
Description:
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.
Treatment:
Drug: Branched-chain amino acid
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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