- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341399
Essential Amino Acid Supplementation in Adult Spinal Deformity Patients
April 15, 2026 updated by: University of Arkansas
Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery
This will be a randomized double-blind placebo controlled clinical trial to determine if supplementing with essential amino acids (EAAs) for two weeks prior to, and 3 months after corrective spinal surgery in adults with spinal deformity can stimulate greater muscle protein turnover and whole-body protein balance, and enhance recovery after surgery when compared to a calorie matched placebo.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shiloah Kviatkovsky, PhD
- Phone Number: 619.677.0792
- Email: skviatkovsky@uams.edu
Study Contact Backup
- Name: David D Church, PhD
- Phone Number: (501) 526-5769
- Email: DChurch@uams.edu
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- University of Arkansas for Medical Sciences
-
Contact:
- Shiloah Kviatkovsky, PhD
- Phone Number: 619-677-0792
- Email: skviatkovsky@uams.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and Females, 40 to 65 years old
- Diagnosed with adult spinal deformity
- Scheduled for ASD corrective procedure at UAMS (>2 weeks prior to surgery)
- Live near Little Rock and scheduled to attend physical therapy in Little Rock
- COVID-19 negative and/ or asymptomatic
Exclusion Criteria:
- Subject who does not/will not eat animal protein sources.
- Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
- Currently pregnant.
- Gave birth or was lactating within previous 12 months.
- History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- Clinically significant weight gain or loss (>5% change) in the last 12 months.
- Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin).
- Diagnosis of autoimmune disease
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Diagnosis of muscular degenerative/dystrophy disease
- Unwilling to fast overnight.
- Unwilling to avoid using other protein or amino-acid supplements during participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Placebo
|
|
Experimental: Essential Amino Acid Supplement Group
|
This intervention will be EAA supplementation of 15g twice a day for two weeks before surgery and then 12 weeks post-surgery in individuals diagnosed with ASD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Protein Synthesis
Time Frame: 24 hours
|
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition
Time Frame: 12 weeks
|
Body composition via DEXA will be used to examine lean body mass, fat mass, and bone mineral density.
Bioelectrical impedance analysis will be used to determine total body water and muscle quality
|
12 weeks
|
|
Handgrip Strength & Walking Ability
Time Frame: 12 weeks
|
Hand grip strength in kg and 6-min walk test ability will be examined
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shiloah Kviatkovsky, UAMS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 15, 2027
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
January 6, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 299302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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