Essential Amino Acid Supplementation for Femoral Fragility Fractures

NCT06050668 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202307209-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Concentration and average count of satellite cells, myonuclei, M1, and M2 Macrophages for Type 1 and Type 2 fibers

  Biopsy results will provide the counts and averages by Type I and Type II fibers for satellite cells, myonuclei, M1 and M2 macrophages.

  Day of Surgery, 3 weeks

• Cross sectional concentration of Type 1 and Type 2 muscle fibers

  Biopsy results will provide the Type I and Type II muscle fiber cross sectional area in µm2.

  Day of Surgery, 3 weeks

• Concentration of myostatin, interleukin-6, and tumor necrosis factor alpha

  Through serum analysis levels of myostatin, interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α) will be measured in pg/mL.

  Day of Surgery, 3 weeks

• Concentration of c-terminal agrin fragments

  Through serum analysis levels of c-terminal agrin fragment will be measured in ng/mL.

  Day of Surgery, 3 weeks

Secondary Outcomes (6)

• Change in skeletal muscle

  Postoperative day 1, 3 weeks, 6 weeks, 12 weeks

• Measurement of lower extremity functioning in older adults

  12 weeks

• Assessment of mobility, balance, walking ability, and fall risk in older adults

  12 weeks

• Measurement of self-reported physical capability

  Post operative day 1, 3 weeks, 6 weeks, 12 weeks, 6 months

• Measurement of self-reported ability to complete activities of daily living (ADL)

  Preoperative, 3 weeks, 6 weeks, 6 months

Study Arms (2)

Essential Amino Acid Supplementation

EXPERIMENTAL

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®.

Combination Product: Essential Amino Acid Supplementation

Standard of Care Postoperative Nutrition

NO INTERVENTION

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 COMBINATION_PRODUCT

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)

Also known as: MEND Repair & Recover

Essential Amino Acid Supplementation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael C Willey: lead
• MEND: collaborator
• Slocum Research & Education Foundation: collaborator

Study Sites (2)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, 97401, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Muscular Atrophy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Michael C Willey, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Willey, MD

CONTACT

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

Ashley S Kochuyt, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 22, 2023
• Study Start: June 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)