Health TrialsbyHealthPanel

Essential Amino Acid Supplementation for Femoral Fragility Fractures

ConditionsFemoral FractureFragility FractureMuscle Atrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorMichael C Willey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospital inpatient

Age ≥ 65 years old on admission

Low-energy mechanism of injury

Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Essential Amino Acid SupplementationExperimental treatment 1 intervention
Group B: Standard of Care Postoperative NutritionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of Surgery, 3 weeks
2

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.

Time frame
Day of Surgery, 3 weeks
3

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.

Time frame
Day of Surgery, 3 weeks
4

Concentration of c-terminal agrin fragments

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

Time frame
Day of Surgery, 3 weeks

Secondary outcomes

1

Change in skeletal muscle

Change in the amount of skeletal muscle mass will be measured by the InBody S10 Body Composition Analyzer and recorded in kilograms.

Time frame
Postoperative day 1, 3 weeks, 6 weeks, 12 weeks
2

Measurement of lower extremity functioning in older adults

Physical performance in relation to lower extremity function will be measured by the Short Physical Performance Battery (SPPB) 14. Individuals are scored on a scale ranging from 0 (worst performance) to 12 (best performance) based on their walking speed, ability to do chair stands, and standing balance.

Time frame
12 weeks
3

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

Physical performance in relation to mobility, balance, walking ability and fall risk will be measured by the Timed Up \& Go (TUG) 15 test. For this test, the research coordinator measures the time required for a participant to rise from an armchair (45 cm height), walk 3 m and return to the chair. Longer times can indicate higher possibility of falling.

Time frame
12 weeks
4

Measurement of self-reported physical capability

Patient-reported physical performance will be measured using the PROMIS-Physical Function survey. PROMIS measures are scored on the T-score metric. a high score means the individual self-reports more of a capability at a certain activity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michael C Willey

Lead sponsor

University of Iowa

Sponsor institution

MEND

Collaborator

Slocum Research & Education Foundation

Collaborator

Source ClinicalTrials.gov
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