Essential Amino Acid Supplementation for Femoral Fragility Fractures

Description

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 Overview

Study Details

Study overview

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.

MEND Repair & Recover Clinical Trial

Essential Amino Acid Supplementation for Femoral Fragility Fractures

Condition
Femoral Fracture
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Health Care, Iowa City, Iowa, United States, 52242

Eugene

Slocum Center for Orthopedics & Sports Medicine, Eugene, Oregon, United States, 97401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Michael C Willey,

Michael C Willey, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2025-12