MEND Repair & Recover Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Iowa
University of Iowa Health Care
RECRUITING
Iowa City
Oregon
Slocum Center for Orthopedics & Sports Medicine
NOT_YET_RECRUITING
Eugene
Contact Information
Primary
Michael C Willey, MD
michael-willey@uiowa.edu
319-384-8452
Backup
Ashley S Kochuyt, BS
ashley-kochuyt@uiowa.edu
319-929-3559
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Essential Amino Acid Supplementation
Subjects randomized to intervention arm of this study will receive essential amino acid (EAA)-based oral nutrition supplementation in addition to standard of care postoperative nutrition. Subjects will take 1 scoop (26.7g) of supplement twice daily for 4 weeks after injury. Supplementation will begin within 72 hours of surgical fixation. The EAA-based supplement used in this clinical trial is MEND™ Repair and Recover®.
No_intervention: Standard of Care Postoperative Nutrition
Subjects randomized to the control arm of this study will receive no intervention. They will receive standard of care postoperative nutrition.
Related Therapeutic Areas
Sponsors
Collaborators: MEND, Slocum Research & Education Foundation
Leads: Michael C Willey

This content was sourced from clinicaltrials.gov