BCAANCT07281846
TIPS With or Without BCAA
A study testing The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS. in people with BCAA and Cirrhosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- BCAA, Cirrhosis, Portal Hypertension Related to Cirrhosis
- What is being tested?
- The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old;
- Diagnosed with cirrhosis complicated by sarcopenia;
- Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS).
Who cannot join
- Hepatocellular carcinoma and/or other malignant tumors;
- Severe cardiopulmonary insufficiency;
- Child-Pugh score > 13 points;
- Spontaneous recurrent hepatic encephalopathy (HE);
- Large spontaneous portosystemic shunt;
- Sepsis; spontaneous bacterial peritonitis (SBP);
- Allergy to any component of the study nutritional supplement;
- High-energy and high-protein diet or use of calcium supplements, vitamin D supplements, or protein/amino acid supplements within 3 months prior to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Yaowei Bai, +8618627162379, baiyaowei918@163.com
baiyaowei918@163.com
About this study
Official title: Transjugular Intrahepatic Portosystemic Shunt With or Without Branched-Chain Amino Acid Supplements in the Treatment of Patients With Cirrhotic Portal Hypertension Complicated by Sarcopenia: A Randomized Controlled Trial
Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. It often leads to portal hypertension and subsequent complications like ascites, gastroesophageal variceal bleeding (20% 6-week mortality), and hepatic encephalopathy (HE). Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for variceal bleeding and refractory ascites per guidelines from EASL, AASLD, and the Chinese Medical Association.
Malnutrition affects 20% of compensated and over 50% of decompensated cirrhotic patients; sarcopenia (severe malnutrition) is linked to higher cirrhosis-related complications, impaired quality of life, survival, and poor prognosis in TIPS-treated patients. Thus, concurrent sarcopenia intervention during TIPS may improve outcomes.
Baveno VII, EASL, and AASLD guidelines recommend branched-chain amino acid (BCAA) and leucine-rich supplements for decompensated cirrhosis to ensure adequate nitrogen intake. RCT evidence shows BCAAs improve skeletal muscle index (SMI) in cirrhotic patients with sarcopenia and reduce HE risk, but evidence for TIPS-treated patients is lacking. This study aims to compare muscle mass changes and clinical prognosis between TIPS patients with sarcopenia, portal hypertension, and variceal bleeding who receive TIPS with or without BCAA supplements.
Read the detailed description
Cirrhosis is a major cause of morbidity and mortality among patients with chronic liver disease worldwide. In 2019, cirrhosis accounted for 2.4% of global deaths. A Global Burden of Disease study (1990-2017) showed that the number of deaths caused by cirrhosis has been on the rise year by year since 1990, imposing a severe health and economic burden on many countries and peoples around the world. Cirrhosis is usually accompanied by the development of portal hypertension, which further leads to complications such as ascites, gastroesophageal variceal bleeding, and hepatic encephalopathy (HE). Among these, the mortality rate of gastroesophageal variceal bleeding reaches as high as 20% within 6 weeks of onset. Currently, according to guidelines issued by the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD), and the Chinese Medical Association, transjugular intrahepatic portosystemic shunt (TIPS) has become an important treatment for variceal bleeding and refractory ascites.
Malnutrition is a common complication of cirrhosis, affecting 20% of patients with compensated cirrhosis and more than 50% of those with decompensated cirrhosis. Sarcopenia is generally regarded as severe malnutrition, and its occurrence is often associated with a higher risk of cirrhosis-related complications (such as hepatic encephalopathy, ascites, and infections), which seriously impairs patients' quality of life and survival. Several studies have shown that sarcopenia is associated with poor prognosis in cirrhotic patients undergoing TIPS treatment. Therefore, concurrent intervention for sarcopenia during TIPS treatment may improve prognosis and thus enhance patient survival.
The Baveno VII guidelines point out that malnutrition increases the risk of poor prognosis in patients with cirrhosis and acute variceal bleeding, and oral nutrition should be initiated as soon as possible. Both the EASL Clinical Practice Guidelines on Nutrition in Chronic Liver Disease and the AASLD Practice Guidance on Malnutrition, Frailty, and Sarcopenia in Patients with Cirrhosis recommend the use of branched-chain amino acid (BCAA) supplements and leucine-rich amino acid supplements in patients with decompensated cirrhosis to achieve adequate nitrogen intake. An RCT study demonstrated that BCAA supplements can improve the skeletal muscle index (SMI) in cirrhotic patients with sarcopenia. Additionally, evidence suggests that BCAA supplements can significantly reduce the risk of hepatic encephalopathy (HE).
Therefore, BCAA supplements may serve as a routine nutritional supplement for cirrhotic patients undergoing TIPS treatment, but relevant evidence is currently lacking. This study aims to compare changes in muscle mass and clinical prognosis between cirrhotic patients with portal hypertension and variceal bleeding complicated by sarcopenia who receive TIPS with or without BCAA supplements, so as to verify our hypothesis.
- Conditions
- BCAA, Cirrhosis, Portal Hypertension Related to Cirrhosis, Sarcopenia, Transjugular Intrahepatic Portosystemic Shunt
- Being tested
- The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS., The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packagin
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, Sarcopenia, Portal Hypertension, Cirrhosis, BCAA
- Medical subject headings
- Fibrosis, Sarcopenia, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.Dietary supplement
This prospective randomized controlled trial (RCT) aims to compare changes in muscle mass and clinical outcomes between sarcopenic cirrhotic patients with portal hypertension and variceal bleeding who undergo transjugular intrahepatic portosystemic shunt (TIPS) plus branched-chain amino acid (BCAA) supplementation versus TIPS plus placebo. Eligible patients are aged 18-75 years, with cirrhosis, sarcopenia (defined by EASL guidelines: L3 skeletal muscle index [L3-SMI] <50 cm²/m² for males, <39 cm²/m² for females, measured via preoperative abdominal CT), and TIPS eligibility due to variceal bleeding or refractory ascites; exclusions include malignancies, severe cardiopulmonary insufficiency, Child-Pugh score >13, recurrent hepatic encephalopathy (HE), and prior use of nutrition supplements within 3 months. TIPS is standardized with 8mm covered Viatorr stents, intraoperative variceal embolization if needed, and a postoperative portal pressure gradient (PPG) target of <12 mmHg or ≥50% base
The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaginDietary supplement
The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaging to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| BCAA Group | Experimental | The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after surgery. Receives: Dietary Supplement: The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS. |
| Non-BCAA Group | Placebo comparator | The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaging to maintain blinding. Receives: Dietary Supplement: The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packagin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the sarcopenia reversal rate between the two groups (BCAA and Non-BCAA)
Sarcopenia is defined per the European Association for the Study of the Liver (EASL) clinical practice guidelines: the skeletal muscle index (SMI) is calculated as the ratio of the total cross-sectional area of all skeletal muscles at the third lumbar (L3) level (measured via abdominal CT, unit: cm²) to the square of height (unit: m²), with males having SMI < 50 cm²/m² and females < 39 cm²/m² diagnosed as sarcopenic. SMI is measured preoperatively and at 3 and 6 months post-TIPS to determine the reversal rate (proportion of patients no longer meeting sarcopenia criteria), and the difference in this rate between the two groups is compared to evaluate the effect of BCAA supplementation.
Measured: 1 year
Differences in Short Physical Performance Battery (SPPB) scores between the two groups (BCAA and Non-BCAA)
The SPPB consists of three subtests: balance test, gait speed test, and Chair Stand Test. Each subtest is scored from 0 to 4 points, with a total score ranging from 0 to 12 points-higher scores indicate better physical fitness. The SPPB is assessed preoperatively and at 3 and 6 months post-TIPS to compare changes in physical performance between the BCAA and Non-BCAA groups, reflecting the effect of BCAA supplementation on functional capacity in cirrhotic patients with sarcopenia.
Measured: 1 year
Secondary outcomes (4)
The cumulative incidence of hepatic encephalopathy (HE) in the two groups (BCAA and Non-BCAA)
Hepatic encephalopathy (HE) is diagnosed and graded in accordance with the West-Haven criteria, with overt HE (OHE) defined as Grades II-IV. Data are collected during follow-up at 3 and 6 months after TIPS to compare whether branched-chain amino acid (BCAA) supplementation reduces the risk of HE compared with placebo. The Kaplan-Meier method is used to plot the cumulative incidence curves of HE in the two groups, and the Log-rank test is applied to compare the differences in the risk of HE occurrence between the two groups.
Measured: 1 year
The cumulative incidence of death in the two groups (BCAA and Non-BCAA)
Death is defined as all-cause mortality occurring during the follow-up period after TIPS. Data on mortality events (including the time and cause of death) are collected through regular follow-up assessments at 3 and 6 months post-TIPS, as well as active follow-up via medical records and telephone inquiries for any unplanned hospitalizations or death reports. The aim is to compare whether branched-chain amino acid (BCAA) supplementation reduces the risk of death compared with placebo. The Kaplan-Meier method is used to plot the cumulative survival curves (and corresponding cumulative mortality curves) of the two groups, and the Log-rank test is applied to compare the differences in mortality risk between the two groups.
Measured: 1 year
The cumulative incidence of Variceal Rebleeding in the two groups (BCAA and Non-BCAA)
Variceal rebleeding is diagnosed in accordance with the Baveno VII consensus criteria, defined as recurrent melena or hematemesis leading to any of the following: hospitalization, blood transfusion requirement, a decrease in hemoglobin of ≥3 g within 24 hours, or death within 6 weeks of the index bleeding event. Relevant data (including the time of rebleeding, clinical manifestations, and diagnostic evidence) are collected during scheduled follow-up at 3 and 6 months post-TIPS, as well as through emergency department and hospitalization records for acute bleeding episodes. The goal is to evaluate whether BCAA supplementation lowers the risk of variceal rebleeding compared with placebo. The Kaplan-Meier method is used to plot the cumulative incidence curves of variceal rebleeding in the two groups, and the Log-rank test is applied to compare the differences in rebleeding risk between the two groups.
Measured: 1 year
The cumulative incidence of Shunt Dysfunction in the two groups (BCAA and Non-BCAA)
Shunt dysfunction is diagnosed based on the following criteria: color Doppler ultrasound detects a maximum shunt tract blood flow velocity ≤50 cm/s, ≥200 cm/s, or no blood flow signal; or recurrence of clinical symptoms (such as variceal rebleeding or refractory ascites) suggestive of shunt malfunction, which is further confirmed by transjugular portography showing >50% stenosis of the shunt tract. Data on shunt function are collected through color Doppler ultrasound examinations during follow-up at 3 and 6 months post-TIPS, as well as through portography for suspected cases. The purpose is to compare whether BCAA supplementation affects the risk of shunt dysfunction compared with placebo. The Kaplan-Meier method is used to plot the cumulative incidence curves of shunt dysfunction in the two groups, and the Log-rank test is applied to compare the differences in the risk of shunt dysfunction between the two groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Nov 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCAAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Science and Technology
- Responsible party
- Principal investigator, Jiacheng Liu, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281846
- Sponsor's protocol ID
- TIPS-BCAA
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transjugular Intrahepatic Portosystemic Shunt With or Without Branched-Chain Amino Acid Supplements in the Treatment of Patients With Cirrhotic Portal Hypertension Complicated by Sarcopenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07281846
- Acronym / sponsor ID
- TIPS-BCAA
- Conditions
- BCAA, Cirrhosis, Portal Hypertension Related to Cirrhosis, Sarcopenia, Transjugular Intrahepatic Portosystemic Shunt
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, Sarcopenia, Portal Hypertension, Cirrhosis, BCAA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Science and Technology
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. It often leads to portal hypertension and subsequent complications like ascites, gastroesophageal variceal bleeding (20% 6-week mortality), and hepatic encephalopathy (HE). Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for variceal bleeding and refractory ascites per guidelines from EASL, AASLD, and the Chinese Medical Association.
Malnutrition affects 20% of compensated and over 50% of decompensated cirrhotic patients; sarcopenia (severe malnutrition) is linked to higher cirrhosis-related complications, impaired quality of life, survival, and poor prognosis in TIPS-treated patients. Thus, concurrent sarcopenia intervention during TIPS may improve outcomes.
Baveno VII, EASL, and AASLD guidelines recommend branched-chain amino acid (BCAA) and leucine-rich supplements for decompensated cirrhosis to ensure adequate nitrogen intake. RCT evidence shows BCAAs improve skeletal muscle index (SMI) in cirrhotic patients with sarcopenia and reduce HE risk, but evidence for TIPS-treated patients is lacking. This study aims to compare muscle mass changes and clinical prognosis between TIPS patients with sarcopenia, portal hypertension, and variceal bleeding who receive TIPS with or without BCAA supplements.
Detailed description
Cirrhosis is a major cause of morbidity and mortality among patients with chronic liver disease worldwide. In 2019, cirrhosis accounted for 2.4% of global deaths. A Global Burden of Disease study (1990-2017) showed that the number of deaths caused by cirrhosis has been on the rise year by year since 1990, imposing a severe health and economic burden on many countries and peoples around the world. Cirrhosis is usually accompanied by the development of portal hypertension, which further leads to complications such as ascites, gastroesophageal variceal bleeding, and hepatic encephalopathy (HE). Among these, the mortality rate of gastroesophageal variceal bleeding reaches as high as 20% within 6 weeks of onset. Currently, according to guidelines issued by the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD), and the Chinese Medical Association, transjugular intrahepatic portosystemic shunt (TIPS) has become an important treatment for variceal bleeding and refractory ascites.
Malnutrition is a common complication of cirrhosis, affecting 20% of patients with compensated cirrhosis and more than 50% of those with decompensated cirrhosis. Sarcopenia is generally regarded as severe malnutrition, and its occurrence is often associated with a higher risk of cirrhosis-related complications (such as hepatic encephalopathy, ascites, and infections), which seriously impairs patients' quality of life and survival. Several studies have shown that sarcopenia is associated with poor prognosis in cirrhotic patients undergoing TIPS treatment. Therefore, concurrent intervention for sarcopenia during TIPS treatment may improve prognosis and thus enhance patient survival.
The Baveno VII guidelines point out that malnutrition increases the risk of poor prognosis in patients with cirrhosis and acute variceal bleeding, and oral nutrition should be initiated as soon as possible. Both the EASL Clinical Practice Guidelines on Nutrition in Chronic Liver Disease and the AASLD Practice Guidance on Malnutrition, Frailty, and Sarcopenia in Patients with Cirrhosis recommend the use of branched-chain amino acid (BCAA) supplements and leucine-rich amino acid supplements in patients with decompensated cirrhosis to achieve adequate nitrogen intake. An RCT study demonstrated that BCAA supplements can improve the skeletal muscle index (SMI) in cirrhotic patients with sarcopenia. Additionally, evidence suggests that BCAA supplements can significantly reduce the risk of hepatic encephalopathy (HE).
Therefore, BCAA supplements may serve as a routine nutritional supplement for cirrhotic patients undergoing TIPS treatment, but relevant evidence is currently lacking. This study aims to compare changes in muscle mass and clinical prognosis between cirrhotic patients with portal hypertension and variceal bleeding complicated by sarcopenia who receive TIPS with or without BCAA supplements, so as to verify our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCAA Group | Experimental | Dietary Supplement: The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after surgery. |
| Non-BCAA Group | Placebo comparator | Dietary Supplement: The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaginThe Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaging to maintain blinding. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years old;
- Diagnosed with cirrhosis complicated by sarcopenia;
- Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS).
Key exclusion criteria (8 listed)
- Hepatocellular carcinoma and/or other malignant tumors;
- Severe cardiopulmonary insufficiency;
- Child-Pugh score > 13 points;
- Spontaneous recurrent hepatic encephalopathy (HE);
- Large spontaneous portosystemic shunt;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.This prospective randomized controlled trial (RCT) aims to compare changes in muscle mass and clinical outcomes between sarcopenic cirrhotic patients with portal hypertension and variceal bleeding who undergo transjugular intrahepatic portosystemic shunt (TIPS) plus branched-chain amino acid (BCAA) supplementation versus TIPS plus placebo. Eligible patients are aged 18-75 years, with cirrhosis, sarcopenia (defined by EASL guidelines: L3 skeletal muscle index [L3-SMI] <50 cm²/m² for males, <39 cm²/m² for females, measured via preoperative abdominal CT), and TIPS eligibility due to variceal bleeding or refractory ascites; exclusions include malignancies, severe cardiopulmonary insufficiency, Child-Pugh score >13, recurrent hepatic encephalopathy (HE), and prior use of nutrition supplements within 3 months. TIPS is standardized with 8mm covered Viatorr stents, intraoperative variceal embolization if needed, and a postoperative portal pressure gradient (PPG) target of <12 mmHg or ≥50% base | Dietary supplement | BCAA Group |
| The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaginThe Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packaging to maintain blinding. | Dietary supplement | Non-BCAA Group |
Primary outcome
Differences in the sarcopenia reversal rate between the two groups (BCAA and Non-BCAA)
Time frame: 1 year
Sarcopenia is defined per the European Association for the Study of the Liver (EASL) clinical practice guidelines: the skeletal muscle index (SMI) is calculated as the ratio of the total cross-sectional area of all skeletal muscles at the third lumbar (L3) level (measured via abdominal CT, unit: cm²) to the square of height (unit: m²), with males having SMI < 50 cm²/m² and females < 39 cm²/m² diagnosed as sarcopenic. SMI is measured preoperatively and at 3 and 6 months post-TIPS to determine the reversal rate (proportion of patients no longer meeting sarcopenia criteria), and the difference in this rate between the two groups is compared to evaluate the effect of BCAA supplementation.
Differences in Short Physical Performance Battery (SPPB) scores between the two groups (BCAA and Non-BCAA)
Time frame: 1 year
The SPPB consists of three subtests: balance test, gait speed test, and Chair Stand Test. Each subtest is scored from 0 to 4 points, with a total score ranging from 0 to 12 points-higher scores indicate better physical fitness. The SPPB is assessed preoperatively and at 3 and 6 months post-TIPS to compare changes in physical performance between the BCAA and Non-BCAA groups, reflecting the effect of BCAA supplementation on functional capacity in cirrhotic patients with sarcopenia.
4 secondary outcomes
The cumulative incidence of hepatic encephalopathy (HE) in the two groups (BCAA and Non-BCAA)
Time frame: 1 year
The cumulative incidence of death in the two groups (BCAA and Non-BCAA)
Time frame: 1 year
The cumulative incidence of Variceal Rebleeding in the two groups (BCAA and Non-BCAA)
Time frame: 1 year
The cumulative incidence of Shunt Dysfunction in the two groups (BCAA and Non-BCAA)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS. in people with BCAA and Cirrhosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaowei Bai (+8618627162379, baiyaowei918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the sarcopenia reversal rate between the two groups (BCAA and Non-BCAA) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.