Essential Amino Acid Supplementation in Adult Spinal Defo... | NCT07341399

Studies
Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

NCT07341399

Sponsor

University of Arkansas

Status

Not yet recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Adult Spinal Deformity

Interventions

Essential Amino Acid Supplement by Amino Co
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Mar 1, 2027Estimated

Completion Date

May 15, 2027Estimated

First Submitted Date

Dec 19, 2025

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Essential Amino Acid Supplement Group	Experimental		Dietary Supplement: Essential Amino Acid Supplement by Amino Co
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle Protein Synthesis	Mixed muscle protein synthesis expressed as the fractional synthetic rate.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Body Composition	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	12 weeks
Handgrip Strength & Walking Ability

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shiloah Kviatkovsky, PhD	Contact	619.677.0792		skviatkovsky@uams.edu
David D Church, PhD	Contact	(501) 526-5769		DChurch@uams.edu

Overall Officials

Name	Affiliation	Role
Shiloah Kviatkovsky	UAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.