Essential amino acid supplementation for patients with femoral fractures
MEND Repair & Recover Clinical Trial
This study is testing if taking essential amino acids for four weeks after surgery can help people with femoral fractures recover better and keep their muscle strength.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Trial ID | NCT06050668 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of a 4-week postoperative essential amino acid (EAA) supplementation on muscle health following femoral fragility fractures. Participants will be randomly assigned to receive either standard care or EAA-based supplementation, with assessments conducted over a 6-month period. The study aims to measure changes in muscle morphology, metabolic activity, inflammation, and physical performance, utilizing muscle biopsies and body composition analysis. The goal is to determine if EAA supplementation can enhance recovery and preserve muscle mass after surgery.
Who should consider this trial
Good fit: Ideal candidates are hospital inpatients aged 65 and older who have sustained a low-energy femoral fracture and are indicated for surgical fixation.
Not a fit: Patients who are non-ambulatory prior to injury or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and muscle health for patients recovering from femoral fractures.
How similar studies have performed: While the specific approach of EAA supplementation post-fracture is novel, similar studies have shown positive outcomes in muscle recovery and health in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Iowa City, Iowa and 1 other locations
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
- Slocum Center for Orthopedics & Sports Medicine — Eugene, Oregon, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Michael C Willey, MD — University of Iowa
- Study coordinator: Michael C Willey, MD
- Email: michael-willey@uiowa.edu
- Phone: 319-384-8452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.