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.
Essential Amino Acid Supplementation for Femoral Fragility Fractures
At a glance
Conditions
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.
Study leadership
- Michael C Willey, MD · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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.