A Phase 3 interventional study of Branched-chain amino acid in Decompensated Cirrhosis and Ascites, sponsored by Mahidol University. Enrolling by invitation at 1 site in Thailand. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Mahidol University · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL.
The main questions it aims to answer are:
Participants will be asked to do following tasks:
The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL.
The main questions it aims to answer are:
Participants will be asked to do following tasks:
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 30 is below the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
5 .Patients who have undergone liver or kidney transplant. 6. Patients with (HIV). 7. Pregnant or lactating patients. 8. Patients who have undergone large volume paracentesis (>5 liters) with intravenous albumin administration on the day of study enrollment. 9. Patients with a history of above-knee amputation surgery. 10. Patients with a history of receiving intravenous albumin administration every 1-2 weeks within the last one month.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral branched-chain amino acid (BCAA) is provided to the patients with a recommended daily intake of approximately 13.68 grams per day. Each sachet contains 6.84 grams of BCAA (valine 1.82 grams, leucine 3.29 grams, isoleucine 1.72 grams), total protein 17.08 grams, carbohydrates 25.48 grams, fat 5.66 grams, providing 221.2 kcal of energy. Each sachet weighs 52 grams and should be mixed with 150 ml of water. The recommended daily intake is 2 sachets, to be consumed after breakfast and dinner. The BCAA provided to the patients comes in pre-packaged silver sachets, with the manufacturing date and expiration date indicated.
Drug: Branched-chain amino acid
Oral branched-chain amino acid is provided to the patients with a recommended daily intake of approximately 13.68 grams per day. Each sachet contains 6.84 grams of BCAA (valine 1.82 grams, leucine 3.29 grams, isoleucine 1.72 grams), total protein 17.08 grams, carbohydrates 25.48 grams, fat 5.66 grams, providing 221.2 kcal of energy. Each sachet weighs 52 grams and should be mixed with 150 ml of water. The recommended daily intake is 2 sachets, to be consumed after breakfast and dinner. The BCAA provided to the patients comes in pre-packaged silver sachets, with the manufacturing date and expiration date indicated.
thigh muscle thickness by ultrasound
Thigh muscle thickness (centimeters) by ultrasound of right thigh will be performed according to these instructions 1. Measure the thickness of the right thigh muscles, which are the rectus femoris and vastus intermedius, at a position one-third between the upper edge of the patella bone to the iliac crest, with the patient lying flat. In that position, measure the thigh muscle thickness using two methods: a. Compression reading: Measure the muscle thickness by pressing the probe head until it cannot be compressed further. b. Feather weight reading: Measure the muscle thickness without applying pressure to the probe head. Take the muscle thickness measurements twice for each method, calculate their averages. Increase in thigh muscle thickness implies better nutritional status.
Time frame: 12 weeks
Average Feather Index
The Average Feather Index (cm/m2) will be calculated by taking average of thigh muscle thickness (centimeter) measured by feather weight reading divided by height (m\^2). Increase in average feather index implies better nutritional status.
Time frame: 12 weeks
Average Compression Index
The Average Compression Index (cm/m2) will be calculated by taking average of thigh muscle thickness (centimeter) measured by compression weight reading divided by height (m\^2). Increase in average compression index implies better nutritional status.
Time frame: 12 weeks
triceps skin fold thickness
Triceps skin fold thickness (TSF, millimeter) will be measured using Lange skin fold caliper at midpoint of non dominant arm.
Time frame: 12 weeks
mid-arm circumferences
Mid-arm circumferences (MAC, centimeters) will be measured using standard measuring tape at midpoint of non dominant arm. Increase of mid-arm circumferences implies better nutritional status.
Time frame: 12 weeks
mid-arm muscle circumferences
Mid-arm muscle circumferences (MAMC, centimeters) will be obtained from calculating the following formula: MAMC (cm) = MAC - (0.314 × TSF \[mm\]). Increase of mid-arm muscle circumferences implies better nutritional status.
Time frame: 12 weeks
skeletal muscle mass
Skeletal muscle mass (kilograms) will be measured using bioelectrical impedance analysis. Increase of skeletal muscle mass implies better nutritional status.
Time frame: 12 weeks
appendicular skeletal muscle mass
Appendicular skeletal muscle mass (kilograms) will be measured using bioelectrical impedance analysis. Increase of appendicular skeletal muscle mass implies better nutritional status.
Time frame: 12 weeks
skeletal muscle index
Skeletal muscle index (kilograms/m\^2) will be measured using bioelectrical impedance analysis. Increase of skeletal muscle index implies better nutritional status.
Time frame: 12 weeks
Fat mass
Fat mass (kilograms) will be measured using bioelectrical impedance analysis.
Time frame: 12 weeks
Handgrip strength
Handgrip strength (kilograms) will be measured three times for each hand using digital handgrip strength dynamometer. Increase of handgrip strength implies better physical performance.
Time frame: 12 weeks
MELD Na Score
MELD Na Score will be calculated at the start and end of study. Decrease of MELD Na Score implies improving of cirrhotic severity.
Time frame: 12 weeks
Child Turcotte Pugh Score
Child Turcotte Pugh Score will be calculated at the start and end of study. Decrease of Child Turcotte Pugh Score implies improving of cirrhotic severity.
Time frame: 12 weeks
Serum albumin
Serum albumin (gram/deciliter) will be measured at the start and end of study. Increase of serum albumin implies better nutritional status.
Time frame: 12 weeks
Plan to share: No — In order to protect patients' confidentiality, we will not share individual participant data.
Ran from Nov 2023 to primary completion in Sep 2025, 22 months.
Of 13 phase 3 interventional studies under Ascites, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 49. This study's 22 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Amino Acids, Branched-Chain