A Phase 2 interventional study of Essential Amino Acid Supplementation in Femoral Fracture, Fragility Fracture and Muscle Atrophy, sponsored by Michael C Willey. Recruiting at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Michael C Willey · Phase 2, Interventional, and Supportive care
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.
This study consists of 7 study visits that occur over 6 months after operative fixation of femoral fragility fracture. Consenting participants will be asked to complete the study assessments/procedures at the time points described below. Patients will be treated with operative fixation of their fracture per standard of care.
Preoperative
Day of Surgery (DOS):
Postoperative Day 1 (POD 1)
All patients will be given logs to keep track of their daily pain, PT and number of meals eaten.
3 Week Clinic Visit:
Supplement Compliance: Patients will be asked to return completed log sheets and if they were randomized to the supplement group, being in their supplement containers to be weighed.
6-Week Clinic Visit:
Supplement compliance
12-week Clinic Visit:
Physical Performance Measures: Objective measures of physical performance (mobility, strength, power, \& balance) will be assessed with the Short Physical Performance Battery (SPPB)14 and the Timed Up \& Go (TUG)15 test. During the SPPB, subjects will complete the following physical assessments - ability to stand for 10 seconds with feet in 3 different positions (together side-by-die, semi-tandem, \& tandem), two timed trials of a 4-meter walk, and time to rise from a chair 5 times. During the TUG, subjects will complete the following physical assessment - time to rise from a chair, walk 3 meters, return, \& sit down. This assessment will be performed by trained study team members.
6-month Phone Call:
186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.
This study's planned enrollment of 60 is close to the median of 61 across 114 interventional studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →Michael C Willey is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Subjects randomized to the control arm of this study will receive no intervention. They will receive standard of care postoperative nutrition.
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
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
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
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
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
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
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
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
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
Measurement of self-reported ability to complete activities of daily living (ADL)
Patient-reported physical performance of activities of daily living will be measured using the Barthel Activities of Daily Living Index. It is a commonly used measure of activities of daily living outcomes for older adults. It measures the ability to perform activities of daily living that are important for maintaining function including feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers from bed to chair and back, mobility on level surfaces, and stairs. Each measure is assessed on a 10-point scale, all scores are combined to give a score out of 100 points. The higher the score the more independent the individual.
Time frame: Preoperative, 3 weeks, 6 weeks, 6 months
Assessment of independent or communal living
Residence at a nursing home or living independently will be recorded at each follow-up visit. Participants living in an assisted living home (apartment or condominium with nursing assistance on call), apartment, single family home, or family member's home are considered living in the community. Living without assistance in a single dwelling will be considered living independently.
Time frame: Preoperative, 3 weeks, 6 weeks12 weeks, 6 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Michael C Willey