Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

University of Arkansas

Status

Begins enrollment in 1 month

Conditions

Adult Spinal Deformity

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Essential Amino Acid Supplement by Amino Co

Study type

Interventional

Funder types

Other

Identifiers

NCT07341399

299302

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.