NCT07634523 Branched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty
| NCT ID | NCT07634523 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-02-06 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Du Hyun Ro, MD, PhD
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT07634523 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 100 Years, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07634523 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07634523 currently recruiting?
Yes, NCT07634523 is actively recruiting participants. Contact the research team at hyunu0331@gmail.com for enrollment information.
Where is the NCT07634523 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07634523 clinical trial?
NCT07634523 is sponsored by Seoul National University Hospital. The principal investigator is Du Hyun Ro, MD, PhD at Seoul National University Hospital. The trial plans to enroll 140 participants.