SarcopeniaPhase 4LIVACT IITNCT07634523
Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty
A Phase 4 study testing Livact Granule in people with Sarcopenia and Total Knee Arthroplasty, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Sarcopenia, Total Knee Arthroplasty
- What is being tested?
- Livact Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 6 Feb 2025to 31 May 2027
- Phase
- Phase 4
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.
Who cannot join
- Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
- Participants who used medications associated with fatty liver within 4 weeks before the first administration of Livact, including thiazolidinediones, sodium glucose cotransporter 2 inhibitors, amiodarone, methotrexate, tamoxifen, valproate, or corticosteroids.
- Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
- Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
- Participants with markedly decreased hepatic protein synthetic function.
- Participants with congenital branched chain amino acid metabolism disorders.
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- Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.
- Participants with a history of high tibial osteotomy.
- Participants with neurologic diseases such as stroke or Parkinson disease.
- Participants with gait disturbance due to causes other than arthritis.
- Participants taking medication for spinal stenosis.
- Participants with a history of hypersensitivity to the investigational product or its components.
- Pregnant or breastfeeding participants.
- Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial.
- Participants judged by the investigator to be inappropriate for participation in the clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 2 recruiting
- Active, not recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Hyunwoo Kim, +82-2-6072-5345, hyunu0331@gmail.com
Du Hyun Ro, MD, PhD
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 06973
Hyomin Cho, gyals3042@naver.com
Sunghwan Kim, MD, PhD
About this study
Official title: The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled Trial
This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty.
Participants are randomly assigned to receive Livact granules 4.15 g three times daily for 3 months after surgery or to receive standard postoperative care without branched chain amino acid administration. Skeletal muscle mass index, physical function, patient reported outcomes, laboratory findings, medication compliance, and adverse events are assessed at baseline, 5 weeks, and 15 weeks after surgery.
- Conditions
- Sarcopenia, Total Knee Arthroplasty
- Being tested
- Livact Granule
- Keywords
- Branched Chain Amino Acids, BCAA, Livact, Skeletal Muscle Mass Index, Bioelectrical Impedance Analysis, Total Knee Arthroplasty, Sarcopenia, Randomized Controlled Trial
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livact GranuleDrug
Also called Branched Chain Amino Acids, BCAA, Livact Granule 4.15 g
Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Branched Chain Amino Acid Group | Experimental | Participants receive Livact granules 4.15 g orally three times daily for 3 months after total knee arthroplasty, in addition to standard postoperative care. Receives: Drug: Livact Granule |
| Control Group | No intervention | Participants receive standard postoperative care without branched chain amino acid administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Measured: Baseline and 15 weeks after surgery
Secondary outcomes (9)
Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery
Hand grip strength is measured using an electronic dynamometer and expressed in kilograms.
Measured: Baseline and 15 weeks after surgery
Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery
Time required to complete five sit to stand repetitions is measured in seconds.
Measured: Baseline and 15 weeks after surgery
Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery
Time required to walk 6 meters is measured in seconds.
Measured: Baseline and 15 weeks after surgery
Change in Lysholm Score From Baseline to 15 Weeks After Surgery
The Lysholm score is used to assess knee symptoms and function. Scores range from 0 to 100, with higher scores indicating better knee function.
Measured: Baseline and 15 weeks after surgery
Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery
Pain is assessed using a visual analog scale, with higher scores indicating greater pain.
Measured: Baseline and 15 weeks after surgery
Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery
The Tegner activity score is used to assess physical activity level. Scores range from 0 to 10, with higher scores indicating a higher activity level.
Measured: Baseline and 15 weeks after surgery
Change in WOMAC Score From Baseline to 15 Weeks After Surgery
The Western Ontario and McMaster Universities Osteoarthritis Index is used to assess pain, stiffness, and physical function. Scores range from 0 to 96, with higher scores indicating worse symptoms.
Measured: Baseline and 15 weeks after surgery
Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery
The International Knee Documentation Committee subjective score is used to assess knee symptoms, function, and sports activities. Scores range from 0 to 100, with higher scores indicating better knee function.
Measured: Baseline and 15 weeks after surgery
Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
Measured: Baseline and 5 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start6 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Du Hyun Ro, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634523
- Sponsor's protocol ID
- 2402-072-1511
- Acronym
- LIVACT IIT
- Status last verified
- May 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the data contain sensitive clinical information and are subject to institutional review board approval, hospital data protection requirements, and participant confidentiality obligations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07634523
- Acronym / sponsor ID
- LIVACT IIT / 2402-072-1511
- Conditions
- Sarcopenia, Total Knee Arthroplasty
- Keywords
- Branched Chain Amino Acids, BCAA, Livact, Skeletal Muscle Mass Index, Bioelectrical Impedance Analysis, Total Knee Arthroplasty, Sarcopenia, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samil Pharmaceutical Co., Ltd.
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Jun 2026 (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.
This multicenter, prospective, randomized controlled trial evaluates whether postoperative administration of branched chain amino acids affects skeletal muscle mass index and sarcopenia related functional outcomes in patients undergoing total knee arthroplasty.
Participants are randomly assigned to receive Livact granules 4.15 g three times daily for 3 months after surgery or to receive standard postoperative care without branched chain amino acid administration. Skeletal muscle mass index, physical function, patient reported outcomes, laboratory findings, medication compliance, and adverse events are assessed at baseline, 5 weeks, and 15 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branched Chain Amino Acid Group | Experimental | Drug: Livact GranuleParticipants receive Livact granules 4.15 g orally three times daily for 3 months after total knee arthroplasty, in addition to standard postoperative care. |
| Control Group | No intervention | –Participants receive standard postoperative care without branched chain amino acid administration. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.
Key exclusion criteria (15 listed)
- Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
- Participants who used medications associated with fatty liver within 4 weeks before the first administration of Livact, including thiazolidinediones, sodium glucose cotransporter 2 inhibitors, amiodarone, methotrexate, tamoxifen, valproate, or corticosteroids.
- Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
- Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
- Participants with markedly decreased hepatic protein synthetic function.
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 |
|---|---|---|
| Livact GranuleAlso: Branched Chain Amino Acids, BCAA, Livact Granule 4.15 gLivact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty. | Drug | Branched Chain Amino Acid Group |
Primary outcome
Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².
9 secondary outcomes
Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in Lysholm Score From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in WOMAC Score From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery
Time frame: Baseline and 15 weeks after surgery
Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery
Time frame: Baseline and 5 weeks after surgery
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 9 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the data contain sensitive clinical information and are subject to institutional review board approval, hospital data protection requirements, and participant confidentiality obligations.
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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.
Du Hyun Ro, MD, PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Livact Granule in people with Sarcopenia and Total Knee Arthroplasty, run by Seoul National University Hospital at 3 sites in South Korea.
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 1 inclusion and 15 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hyunwoo Kim (+82-2-6072-5345, hyunu0331@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal Muscle Mass Index From Baseline to 15 Weeks After Surgery (time frame: Baseline and 15 weeks after surgery). 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 9 Jun 2026.