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Enrolling by Invitation

NCT Number: NCT07341399

Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

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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Key information

Conditions

Adult Spinal Deformity

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Muscle Protein Synthesis

    Time frame: 24 hours

    Mixed muscle protein synthesis expressed as the fractional synthetic rate.

Secondary outcomes

  1. Body Composition

    Time frame: 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

  2. Handgrip Strength & Walking Ability

    Time frame: 12 weeks

    Hand grip strength in kg and 6-min walk test ability will be examined

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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