Essential Amino Acid Supplementation for Femoral Fragility Fractures

Launched by MICHAEL C WILLEY · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how a special type of dietary supplement called essential amino acids (EAAs) can help patients recover after a femoral fragility fracture, which is a break in the thigh bone often caused by low-energy injuries like falls. The study will last for four weeks and will look at whether these supplements can improve muscle strength, decrease inflammation, and help maintain muscle size and function for up to six months after the injury. Participants will be randomly assigned to either receive the EAA supplements or continue with standard care, which does not involve any additional dietary changes.

To be eligible for this trial, participants must be at least 65 years old and have been hospitalized for a femur fracture that requires surgery. They should also be able to give their consent to join the study. However, individuals with certain conditions, such as severe cognitive impairment or specific medical devices like pacemakers, are not eligible. Those who participate can expect to have regular follow-ups to monitor their recovery and the effects of the supplement on their muscle health. This study aims to find out if EAAs can play a beneficial role in helping older adults heal and regain their strength after a fracture.

Gender

ALL

Eligibility criteria

• 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)