Essential Amino Acids for Adult Spinal Deformity

SK
DD
Overseen ByDavid D Church, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking an essential amino acid supplement (Essential Amino Acid Supplement by Amino Co) before and after spinal surgery can improve recovery for adults with a spinal deformity. Researchers aim to determine if the supplement boosts muscle health and overall recovery compared to a placebo. The trial is open to adults diagnosed with spinal deformity who are scheduled for surgery and live near Little Rock, Arkansas. As an unphased trial, it offers a unique opportunity to contribute to scientific knowledge and potentially enhance recovery outcomes.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that essential amino acid (EAA) supplements are generally safe because they occur naturally in many foods. Studies indicate that EAA supplements are affordable and safe when used correctly, making them unlikely to cause harm.

While specific information on side effects from the supplements used in this trial is unavailable, EAAs are common and have been used safely in other contexts. Research has not reported serious side effects directly linked to EAA supplements. However, paying attention to how the body reacts when starting any new supplement is always advisable.12345

Why are researchers excited about this trial?

Unlike traditional treatments for adult spinal deformity, which often rely on surgical intervention or pain management with medications, the Essential Amino Acid Supplement by Amino Co offers a non-invasive approach. Researchers are excited about this treatment because it targets muscle health and recovery at a cellular level using a specialized blend of essential amino acids. These nutrients are crucial building blocks for protein synthesis, potentially improving muscle function and support around the spine, which might contribute to better posture and reduced pain. This approach could offer a novel, less invasive option for managing spinal deformity symptoms, enhancing quality of life without the need for surgery or heavy medication reliance.

What evidence suggests that this treatment might be an effective treatment for adult spinal deformity?

Research has shown that essential amino acid (EAA) supplements can aid muscle recovery after surgery. Ten studies have found that EAA supplements might prevent muscle loss following bone and joint surgeries. This trial will compare an Essential Amino Acid Supplement with a placebo to evaluate its effectiveness in patients with adult spinal deformity. Maintaining muscle strength is crucial for these patients, as it can enhance recovery. Good nutrition, including EAAs, has been linked to improved recovery after spinal surgery. Although more research is needed to confirm these findings, early evidence suggests that EAAs might aid recovery by enhancing the body's use and maintenance of protein.12346

Who Is on the Research Team?

SK

Shiloah Kviatkovsky

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for adults with spinal deformity who are scheduled for corrective surgery. Participants will take a supplement or placebo before and after surgery to see if it helps recovery.

Inclusion Criteria

I am scheduled for ASD surgery at UAMS in more than 2 weeks.
I live near Little Rock and will attend physical therapy there.
I do not have COVID-19 or any related symptoms.
See 2 more

Exclusion Criteria

Unwilling to fast overnight
I am currently on hormone therapy such as testosterone.
I have been diagnosed with a muscle degeneration disease.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Supplementation

Participants receive essential amino acids (EAAs) supplementation for two weeks prior to surgery

2 weeks

Surgery

Participants undergo corrective spinal surgery

1 day

Post-surgery Supplementation

Participants continue essential amino acids (EAAs) supplementation for 3 months after surgery

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Essential Amino Acid Supplement by Amino Co

Trial Overview

The study tests whether taking essential amino acid supplements improves muscle protein turnover and overall protein balance, aiding in recovery post-spinal surgery, compared to a calorie-matched placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Essential Amino Acid Supplement GroupExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+

Citations

Essential Amino Acid Supplementation in Adult Spinal ...

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 ...

Essential Amino Acid Supplementation in Adult Spinal ...

Males and Females, 40 to 65 years old · Diagnosed with adult spinal deformity · Scheduled for ASD corrective procedure at UAMS (>2 weeks prior to ...

Amino Acid Supplementation May Help Prevent Muscle ...

Results: Ten RCTs evaluating EAA supplementation ... Instrumentation-related complications of multilevel fusions for adult spinal deformity ...

A Systematic Review of Randomized Clinical Trials

Instrumentation-Related Complications of Multilevel Fusions for Adult Spinal Deformity Patients Over Age 65: Surgical Considerations and Treatment Options ...

Nutritional support for enhanced recovery programs in ...

In fact, “recent weight loss” was found to be a predictor for “non-home discharge” in surgery for adult spinal deformity [20]. The Malnutrition Universal ...

Bone and Tendon Graft Substitutes and Adjuncts

Use of recombinant bone morphogenetic protein is associated with reduced risk of reoperation after spine fusion for adult spinal deformity. Spine (Phila Pa 1976) ...