Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty

NCT07634523 | Recruiting Phase 4

• 1 other identifier: 2402-072-1511
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Branched Chain Amino Acids; BCAA; Livact; Skeletal Muscle Mass Index; Bioelectrical Impedance Analysis; Total Knee Arthroplasty; Sarcopenia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Hand Grip Strength From Baseline to 15 Weeks After Surgery

  Baseline and 15 weeks after surgery

• Change in Five Times Sit to Stand Test Time From Baseline to 15 Weeks After Surgery

  Baseline and 15 weeks after surgery

• Change in 6 Meter Walk Test Time From Baseline to 15 Weeks After Surgery

  Baseline and 15 weeks after surgery

• Change in Lysholm Score From Baseline to 15 Weeks After Surgery

  Baseline and 15 weeks after surgery

• Change in Pain Visual Analog Scale Score From Baseline to 15 Weeks After Surgery

  Baseline and 15 weeks after surgery

Study Arms (2)

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.

Drug: Livact Granule

Control Group

NO INTERVENTION

Participants receive standard postoperative care without branched chain amino acid administration.

Interventions

Livact Granule DRUG

Livact granules 4.15 g are administered orally, one packet three times daily after meals for 3 months after total knee arthroplasty.

Also known as: Branched Chain Amino Acids, BCAA, Livact Granule 4.15 g

Branched Chain Amino Acid Group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samil Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, Seoul, 06973, South Korea

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Du Hyun Ro, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyunwoo Kim

CONTACT

+82-2-6072-5345; hyunu0331@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: February 6, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)