Branched chain amino acids after knee replacement to help muscle

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter randomized trial, adults aged 40–100 undergoing total knee arthroplasty are assigned to receive Livact granules (4.15 g) three times daily for 3 months after surgery or standard postoperative care. The study measures skeletal muscle mass index, physical function, patient-reported outcomes, labs, medication adherence, and adverse events at baseline, 5 weeks, and 15 weeks post-surgery. Participants are closely monitored for safety and tolerability of the intervention. The aim is to determine if postoperative BCAA supplementation improves sarcopenia-related outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting
• Chung-Ang University Hospital
  Seoul, Seoul, South Korea Recruiting
• CHA Bundang Medical Center
  Seongnam-si, Gyeonggi-do, South Korea Active not recruiting

Study contacts

• Principal investigator: Du Hyun Ro, MD, PhD — Seoul National University Hospital
• Study coordinator: Hyunwoo Kim
• Email: hyunu0331@gmail.com
• Phone: +82-2-6072-5345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.