University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Not Yet Recruiting
NCT Number: NCT07341399
Essential Amino Acid Supplementation in Adult Spinal Deformity Patients
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
40 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Essential Amino Acid Supplement by Amino Co
Dietary SupplementThis 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
Placebo
Dietary SupplementPlacebo
Primary outcomes
-
Muscle Protein Synthesis
Time frame: 24 hours
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
Secondary outcomes
-
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
-
Handgrip Strength & Walking Ability
Time frame: 12 weeks
Hand grip strength in kg and 6-min walk test ability will be examined
Study contacts
Contact information is provided by the study sponsor or research team.
David D Church, PhD
CONTACT
Shiloah Kviatkovsky, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
University of Arkansas
Other
Registry information
Official study title
Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 14, 2026
- Registry last updated
- Jun 12, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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