Essential Amino Acid Supplementation for Femoral Fragility Fractures

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Michael C Willey
Study ID
NCT06050668
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Femoral Fracture
  • Fragility Fracture
  • Muscle Atrophy

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Jun 17, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Ashley S Kochuyt, BS
[email protected]
Slocum Center for Orthopedics & Sports MedicineEugeneOregon97401
Tessa Kirkpatrick
[email protected]
5418680658

Find similar trials in Iowa City, IA

By research site
University of Iowa Health Care· Iowa City, IASlocum Center for Orthopedics & Sports Medicine· Eugene, OR

Related Studies