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NCT Number: NCT07634523

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

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.

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Key information

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Branched Chain Amino Acids, BCAA, Livact Granule 4.15 g

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline and 15 weeks after surgery

    Hand grip strength is measured using an electronic dynamometer and expressed in kilograms.

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

    Time frame: Baseline and 15 weeks after surgery

    Time required to complete five sit to stand repetitions is measured in seconds.

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

    Time frame: Baseline and 15 weeks after surgery

    Time required to walk 6 meters is measured in seconds.

  4. Change in Lysholm Score From Baseline to 15 Weeks After Surgery

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 15 weeks after surgery

    Pain is assessed using a visual analog scale, with higher scores indicating greater pain.

  6. Change in Tegner Activity Score From Baseline to 15 Weeks After Surgery

    Time frame: Baseline and 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.

  7. Change in WOMAC Score From Baseline to 15 Weeks After Surgery

    Time frame: Baseline and 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.

  8. Change in IKDC Subjective Score From Baseline to 15 Weeks After Surgery

    Time frame: Baseline and 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.

  9. Change in Skeletal Muscle Mass Index From Baseline to 5 Weeks After Surgery

    Time frame: Baseline and 5 weeks after surgery

    Skeletal muscle mass index is calculated from bioelectrical impedance analysis and expressed as kg/m².

Study contacts

Contact information is provided by the study sponsor or research team.

Hyunwoo Kim

CONTACT

[email protected]

+82-2-6072-5345

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Samil Pharmaceutical Co., Ltd.

Registry information

Official study title

The Effect of BCAA on Sarcopenia in Total Knee Arthroplasty Patients: A Multi-center, Randomized Controlled Trial

Acronym: LIVACT IIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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