RECRUITING Phase 2 ClinicalTrials.gov

Essential Amino Acid Supplementation for Femoral Fragility Fractures

Sponsor: Michael C Willey • ClinicalTrials.gov ID: NCT06050668

Registry updated: 2026-10-07

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Description

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.

Interventions

Essential Amino Acid Supplementation (Combination product)
Powdered supplement that can be mixed into beverage of choice. Ingredients: Zinc, Vitamin A, Vitamin C, Whey Protein, Leucine, Calcium, Vitamin D, Glutamine, Boron, Turmeric, Bioperine, Iron, β-hydroxy β-methylbutyrate (HMB)

Eligibility criteria

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)

Conditions

Femoral Fracture Fragility Fracture Muscle Atrophy

Locations

University of Iowa Health Care — Iowa City, Iowa, United States
Slocum Center for Orthopedics & Sports Medicine — Eugene, Oregon, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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