Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Spinal Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Essential Amino Acid Supplement Group

Group Type EXPERIMENTAL

Essential Amino Acid Supplement by Amino Co

Intervention Type 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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No