Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-100
SponsorSeoul National University Hospital
About this 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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Livact Granule
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Samil Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov