Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty (LIVACT IIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Total Knee Arthroplasty
• Intervention / Treatment: Drug: Livact Granule

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hyunwoo Kim; Phone Number: +82-2-6072-5345; Email: hyunu0331@gmail.com

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • Active, not recruiting
      • CHA Bundang Medical Center
  • Seoul
    • Seoul, Seoul, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Hyunwoo Kim; Phone Number: +82-2-6072-5345; Email: hyunu0331@gmail.com
      • Principal Investigator: Du Hyun Ro, MD, PhD
    • Seoul, Seoul, South Korea, 06973
      • Recruiting
      • Chung-Ang University Hospital
      • Contact: Hyomin Cho; Email: gyals3042@naver.com
      • Principal Investigator: Sunghwan Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged 40 to 100 years who are scheduled to undergo total knee arthroplasty.

Exclusion Criteria:

1. Participants who used antiretroviral agents within 4 weeks before the first administration of Livact.
2. 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.
3. Participants who used branched chain amino acid products or multinutritional supplements within 4 weeks before the first administration of Livact.
4. Participants who used pain medications other than those prescribed for total knee arthroplasty treatment within 2 weeks before the first administration of Livact.
5. Participants with markedly decreased hepatic protein synthetic function.
6. Participants with congenital branched chain amino acid metabolism disorders.
7. Participants with hereditary galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.
8. Participants with a history of high tibial osteotomy.
9. Participants with neurologic diseases such as stroke or Parkinson disease.
10. Participants with gait disturbance due to causes other than arthritis.
11. Participants taking medication for spinal stenosis.
12. Participants with a history of hypersensitivity to the investigational product or its components.
13. Pregnant or breastfeeding participants.
14. Participants planning pregnancy during the trial or who have the possibility of pregnancy but do not agree to use appropriate contraception during the trial.
15. Participants judged by the investigator to be inappropriate for participation in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Branched Chain Amino Acid Group; Participants receive Livact granules 4.15 g orally three times daily for 3 months after total knee arthroplasty, in addition to standard postoperative care.	Drug: Livact Granule; Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.; Other Names: BCAA; Branched Chain Amino Acids; Livact Granule 4.15 g
No Intervention: Control Group; Participants receive standard postoperative care without branched chain amino acid administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 15 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and 5 weeks after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Samil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Du Hyun Ro, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Total Knee Arthroplasty; Sarcopenia; Branched Chain Amino Acids; Bioelectrical Impedance Analysis; BCAA; Skeletal Muscle Mass Index; Livact
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia; Amino Acids, Peptides, and Proteins; Amino Acids
• Other Study ID Numbers: 2402-072-1511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No