Adult Spinal DeformityNCT07341399
Essential Amino Acid Supplementation in Adult Spinal Deformity Patients
A study testing Essential Amino Acid Supplement by Amino Co in people with Adult Spinal Deformity, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adult Spinal Deformity
- What is being tested?
- Essential Amino Acid Supplement by Amino Co
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
About this study
Official title: Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery
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
- Being tested
- Essential Amino Acid Supplement by Amino Co, Placebo
- Keywords
- essential amino acids, protein balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino Acid Supplement by Amino CoDietary 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
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acid Supplement Group | Experimental | Not described Receives: Dietary Supplement: Essential Amino Acid Supplement by Amino Co |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 12 weeks
Handgrip Strength & Walking Ability
Hand grip strength in kg and 6-min walk test ability will be examined
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Spinal DeformityStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiloah Kviatkovsky, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341399
- Sponsor's protocol ID
- 299302
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EAA Consumption on Recovery and Rehabilitation in Adult Spinal Deformity (ASD) Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT07341399
- Acronym / sponsor ID
- 299302
- Conditions
- Adult Spinal Deformity
- Keywords
- essential amino acids, protein balance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acid Supplement Group | Experimental | Dietary Supplement: Essential Amino Acid Supplement by Amino Co |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Amino Acid Supplement by Amino CoThis 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 | Dietary supplement | Essential Amino Acid Supplement Group |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Muscle Protein Synthesis
Time frame: 24 hours
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
2 secondary outcomes
Body Composition
Time frame: 12 weeks
Handgrip Strength & Walking Ability
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiloah Kviatkovsky principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Amino Acid Supplement by Amino Co in people with Adult Spinal Deformity, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.