Essential Amino Acid Supplementation in Adult Spinal Deformity Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Essential Amino Acid Supplement by Amino Co, Placebo.
- Who it may be relevant to
- Registry conditions: Adult Spinal Deformity. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery
Overview
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.
Interventions
- Dietary supplement Essential Amino Acid Supplement by Amino Co
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 - Dietary supplement Placebo
Placebo
Primary outcome measures
- Muscle Protein Synthesis [Time frame: 24 hours]
Secondary outcome measures (2)
- Body Composition [Time frame: 12 weeks]
- Handgrip Strength & Walking Ability [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Arkansas for Medical Sciences — Little Rock
Identifiers
NCT: NCT07341399 · 299302