Essential Amino Acid Supplementation for Femoral Fragility Fractures
United States60 participantsStarted 2024-06-17
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
Timeframe: Day of Surgery, 3 weeks
2
Cross sectional concentration of Type 1 and Type 2 muscle fibers
Timeframe: Day of Surgery, 3 weeks
3
Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha