Phase 2RecruitingAge-related condition
Essential Amino Acid Supplementation for Femoral Fragility Fractures
MEND Repair & Recover Clinical Trial
- Sponsor
- Michael C Willey (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Femoral Fracture; Fragility Fracture; Muscle Atrophy
- Interventions
- Essential Amino Acid Supplementation
- Ages
- older adults
- Registry
- NCT06050668
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers
- Cross sectional concentration of Type 1 and Type 2 muscle fibers
- Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha
- Concentration of c-terminal agrin fragments
History
Primary completion expected
Last registry update
Started
Registered