RECRUITING

Essential Amino Acid Supplementation for Femoral Fragility Fractures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

MEND Repair & Recover Clinical Trial

Quick Facts

Study Start:2024-06-17
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06050668

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.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hospital inpatient
  2. * Age ≥ 65 years old on admission
  3. * Low-energy mechanism of injury
  4. * Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)
  5. * Indicated for surgical fixation
  6. * Able to provide informed consent
  1. * Part of a vulnerable population (ex: Incarcerated, Non-English speaking)
  2. * Cognitive impairment (MMSE score ≤ 17)
  3. * Electrical medical implant (ex: Pacemaker/Defibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)
  4. * Non-ambulatory prior to injury
  5. * Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)
  6. * Concern for inability to complete follow-up
  7. * Hemi or total arthroplasty (joint replacement)
  8. * Patients with a historical diagnosis of chronic kidney disease (CKD)

Contacts and Locations

Study Contact

Michael C Willey, MD
CONTACT
319-384-8452
michael-willey@uiowa.edu
Ashley S Kochuyt, BS
CONTACT
319-929-3559
ashley-kochuyt@uiowa.edu

Principal Investigator

Michael C Willey, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Health Care
Iowa City, Iowa, 52242
United States
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, 97401
United States

Collaborators and Investigators

Sponsor: Michael C Willey

  • Michael C Willey, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-06-17
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Femoral Fracture
  • Fragility Fracture
  • Muscle Atrophy