Essential Amino Acid Supplementation for Femoral Fragility Fractures

This study is looking at how a powdered supplement called Essential Amino Acid (EAA) Supplementation affects muscle recovery after a femoral fragility fracture (a broken thigh bone from a minor fall). The supplement contains ingredients like Zinc, Vitamin A, Vitamin C, Whey Protein, Leucine, Calcium, Vitamin D, Glutamine, Boron, Turmeric, Bioperine, Iron, and β-hydroxy β-methylbutyrate (HMB). Researchers want to see if taking this supplement for 4 weeks after surgery can help increase muscle activity, reduce swelling, build muscle, and keep muscle mass and physical ability strong for up to 6 months. You might be able to join if you are 65 or older, are in the hospital with a low-energy femur fracture that needs surgery, and can give informed consent. The study aims to enroll 60 participants, but its current status is unclear.

Study design
This study will involve 60 participants who will be randomly assigned to either receive the Essential Amino Acid Supplementation or standard care (no dietary intervention) in a 1:1 ratio.
What's involved
If you join, you will have 7 study visits over 6 months after your fracture surgery. You will also have a muscle biopsy and blood draws on the day of surgery and at 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their surgery to assess muscle mass and physical performance.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06050668

Essential Amino Acid Supplementation for Femoral Fragility Fractures

Recruiting
PHASE2Ages 65+InterventionalSupportive care
Michael C Willey
~60 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Essential Amino Acid Supplementation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
Measured over Day of Surgery, 3 weeks
+3 more outcomes measured
Femoral Fracture
Fragility Fracture
Muscle Atrophy

NCT06050668

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Slocum Center for Orthopedics & Sports Medicine

    Eugene, Oregonstudy coordinator listed

    Not yet recruiting

  • University of Iowa Health Care

    Iowa City, Iowastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Michael C Willey, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)
  • Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibersDay 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 fibersDay 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 alphaDay 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 fragmentsDay of Surgery, 3 weeks

    Through serum analysis levels of c-terminal agrin fragment will be measured in ng/mL.