Actively Recruiting
MEND Repair & Recover Clinical Trial for Essential Amino Acid Supplementation in Femoral Fragility Fractures
Led by Michael C Willey · Updated on 2026-04-15
60
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Michael C Willey
Lead Sponsor
M
MEND
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is studying older adults aged 65 and above who have experienced a femoral fragility fracture requiring surgical fixation. It aims to evaluate the effects of essential amino acid (EAA)-based supplementation on muscle health after surgery. Researchers want to see whether this supplementation can improve muscle activity, reduce inflammation, increase muscle fiber size, and help maintain muscle mass and physical function up to six months following the injury. Participants will be randomly assigned to one of two groups: one receiving standard postoperative nutrition without dietary supplements, and the other receiving EAA-based oral supplements twice daily for four weeks starting within 72 hours after surgery. The EAA supplement used is MEND™ Repair and Recover®. Both groups will receive usual care for their fractures, including operative fixation and standard nutrition. During the study, participants will attend seven visits over six months where various assessments will be conducted. These include muscle biopsies, blood tests for inflammation markers, body composition measurements, pain and physical function surveys, nutritional screenings, and physical performance tests like walking and balance evaluations. Researchers will also monitor supplement adherence, record living arrangements, and track any side effects or falls. The study will measure muscle cell concentrations, inflammation levels, muscle fiber size, and physical abilities at different time points to assess the impact of the supplementation.
CONDITIONS
Brief Title
Essential Amino Acid Supplementation for Femoral Fragility Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospital inpatient
- Age 65 years or older on admission
- Injury from a low-energy mechanism
- Diagnosed with femur fracture (OTA 31, 32, or 33 fracture)
- Scheduled for surgical fixation
- Able to provide informed consent
You will not qualify if you...
- Part of a vulnerable population (e.g., incarcerated, non-English speaking)
- Cognitive impairment with MMSE score 17 or lower
- Having an electrical medical implant (e.g., pacemaker, defibrillator, insulin pump)
- Non-ambulatory before the injury
- Unable to consume oral diet or allergic to supplement ingredients (e.g., milk allergy)
- Concerns about completing follow-up visits
- Having hemi or total joint replacement (arthroplasty)
- History of chronic kidney disease (CKD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery and 1 day post surgery plus 4 weeks supplementation
Participants undergo surgical fixation of femoral fragility fracture per standard of care. Muscle biopsies and blood samples are collected on the day of surgery. On the first postoperative day, body composition and various surveys assessing pain, nutrition, and physical function are completed. Participants in the supplement group begin essential amino acid supplementation twice daily for 4 weeks starting within 72 hours after surgery.
1 surgery day visit and 1 postoperative day visit (in-person)
Duration - Up to 12 weeks after surgery
Participants attend clinic visits at 3 weeks, 6 weeks, and 12 weeks after surgery for muscle biopsies, blood samples, body composition assessments, surveys on pain and physical function, nutrition assessments, physical performance tests, and supplement compliance checks. Residence status and activities of daily living are also recorded.
3 clinic visits at 3 weeks, 6 weeks, and 12 weeks (in-person)
Duration - 6 months after surgery
Participants are followed up with a phone call at 6 months after surgery to assess physical function, activities of daily living, and residence status.
1 phone call follow-up
Trial Site Locations
Total: 2 locations
1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States, 97401
Not Yet Recruiting
Research Team
M
Michael C Willey, MD
A
Ashley S Kochuyt, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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