Essential Amino Acid Supplementation for Femoral Fragility Fractures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorMichael C Willey
About this trial
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
Qualifiers
Hospital inpatient
Age ≥ 65 years old on admission
Low-energy mechanism of injury
Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Essential Amino Acid Supplementation
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Michael C Willey
Lead sponsor
University of Iowa
Sponsor institution
MEND
Collaborator
Slocum Research & Education Foundation
Collaborator
Source ClinicalTrials.gov