MEND Repair & Recover Clinical Trial
Michael C Willey
Summary
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. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.
Description
This study consists of 7 study visits that occur over 6 months after operative fixation of femoral fragility fracture. Consenting participants will be asked to complete the study assessments/procedures at the time points described below. Patients will be treated with operative fixation of their fracture per standard of care. Preoperative * Mini-Mental State Examination (MMSE-2®): This is a screening tool for cognitive impairment and will be used to determine eligibility for the study. * Subjects will be randomized to the intervention arm or control arm in a 1:1 ratio. Subjects randomized to…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductEssential 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)
Locations (2)
- University of Iowa Health CareIowa City, Iowa
- Slocum Center for Orthopedics & Sports MedicineEugene, Oregon