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Essential Amino Acid Supplementation for Femoral Fragility Fractures

RecruitingPhase 2Ages 65 Years - anyAllMichael C Willey
NCT06050668 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Hospital inpatient * Age ≥ 65 years old on admission * Low-energy mechanism of injury * Diagnosis of femur fracture (OTA 31, 32, or 33 fracture) * Indicated for surgical fixation * Able to provide informed consent Exclusion Criteria: * Part of a vulnerable population (ex: Incarcerated, Non-English speaking) * Cognitive impairment (MMSE score ≤ 17) * Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator) * Non-ambulatory prior to injury * Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy) * Concern for inability to complete follow-up * Hemi or total arthroplasty (joint replacement) * Patients with a historical diagnosis of chronic kidney disease (CKD)
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What it tests

  • Essential Amino Acid Supplementation
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Where

2 sites
University of Iowa Health Care
Iowa City, United States
Slocum Center for Orthopedics & Sports Medicine
Eugene, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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