Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

NCT07341399 | Not Yet Recruiting

• 1 other identifier: 299302
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Spinal Deformity

Keywords

essential amino acids; protein balance

Outcome Measures

Primary Outcomes (1)

• Muscle Protein Synthesis

  Mixed muscle protein synthesis expressed as the fractional synthetic rate.

  24 hours

Secondary Outcomes (2)

• Body Composition

  12 weeks

• Handgrip Strength & Walking Ability

  12 weeks

Study Arms (2)

Essential Amino Acid Supplement Group

EXPERIMENTAL

Dietary Supplement: Essential Amino Acid Supplement by Amino Co

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Essential Amino Acid Supplement by Amino Co DIETARY_SUPPLEMENT

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

Essential Amino Acid Supplement Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Study Officials

• Shiloah Kviatkovsky

  UAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiloah Kviatkovsky, PhD

CONTACT

619.677.0792; skviatkovsky@uams.edu

David D Church, PhD

CONTACT

(501) 526-5769; DChurch@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: June 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)