Recruiting
Phase 2

Essential Amino Acids

Sponsor:

Michael C Willey

Code:

NCT06050668

Conditions

Femoral Fracture

Fragility Fracture

Muscle Atrophy

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Essential Amino Acid Supplementation

Study Details

Brief 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.

Conditions

Femoral Fracture

Fragility Fracture

Muscle Atrophy

Study ID

NCT06050668

Start date

Jun 17, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Essential 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)

Primary outcome measure

  • Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers [ Time Frame: Day of Surgery, 3 weeks ]
  • Cross sectional concentration of Type 1 and Type 2 muscle fibers [ Time Frame: Day of Surgery, 3 weeks ]
  • Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha [ Time Frame: Day of Surgery, 3 weeks ]
  • Concentration of c-terminal agrin fragments [ Time Frame: Day of Surgery, 3 weeks ]

Central Contacts and Locations

Central contacts

Michael C Willey, MD

319-384-8452michael-willey@uiowa.edu

Ashley S Kochuyt, BS

319-929-3559ashley-kochuyt@uiowa.edu

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Ashley S Kochuyt, BS

ashley-kochuyt@uiowa.edu

More Information

Sponsor

Michael C Willey

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michael C Willey on 2026-04-15.