NCT06050668 · Michael C Willey
Essential Amino Acid Supplementation for Femoral Fragility Fractures
What this study is about
This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture.
View original scientific 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.
Interventions
COMBINATION_PRODUCT
Essential Amino Acid Supplementation
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)
Primary outcome measures
Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
Time frame: Day of Surgery, 3 weeks
Biopsy results will provide the counts and averages by Type I and Type II fibers for satellite cells, myonuclei, M1 and M2 macrophages.
Cross sectional concentration of Type 1 and Type 2 muscle fibers
Time frame: Day of Surgery, 3 weeks
Biopsy results will provide the Type I and Type II muscle fiber cross sectional area in µm2.
Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha
Time frame: Day of Surgery, 3 weeks
Through serum analysis levels of myostatin, interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α) will be measured in pg/mL.
Concentration of c-terminal agrin fragments
Time frame: Day of Surgery, 3 weeks
Through serum analysis levels of c-terminal agrin fragment will be measured in ng/mL.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Iowa City, Iowa
- Eugene, Oregon
Collaborators
MEND, Slocum Research & Education Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations