Adult Spinal Deformity
Conditions
Keywords
essential amino acids, protein balance
Brief summary
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_SUPPLEMENTEssential 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_SUPPLEMENTPlacebo
Placebo
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of essential amino acid (EAA) supplementation on recovery and rehabilitation outcomes in adults undergoing corrective surgery for adult spinal deformity (ASD). Participants will be randomized to receive either an EAA supplement or an isocaloric placebo beginning two weeks prior to surgery and continuing for three months postoperatively. The primary objectives are to determine whether perioperative EAA supplementation improves muscle protein turnover and enhances functional recovery compared with placebo. Outcomes will include measures of muscle protein kinetics using stable isotope techniques, body composition, functional performance (handgrip strength and six-minute walk test), and clinical recovery outcomes during postoperative rehabilitation.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Protein Synthesis | 24 hours | Mixed muscle protein synthesis expressed as the fractional synthetic rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 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 | 12 weeks | Hand grip strength in kg and 6-min walk test ability will be examined |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShiloah Kviatkovsky
UAMS
Outcome results
None listed