NCT06050668 Essential Amino Acid Supplementation for Femoral Fragility Fractures
| NCT ID | NCT06050668 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michael C Willey |
| Condition | Femoral Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2026-07 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-06-17 with a primary completion date of 2026-07.
⚠ 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 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.
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)
Contact & Investigator
Michael C Willey, MD
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT06050668 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Femoral Fracture. 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 NCT06050668 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06050668 currently recruiting?
Yes, NCT06050668 is actively recruiting participants. Contact the research team at michael-willey@uiowa.edu for enrollment information.
Where is the NCT06050668 trial being conducted?
This trial is being conducted at Iowa City, United States, Eugene, United States.
Who is sponsoring the NCT06050668 clinical trial?
NCT06050668 is sponsored by Michael C Willey. The principal investigator is Michael C Willey, MD at University of Iowa. The trial plans to enroll 60 participants.