Nutritional Supplementation for Spinal Stenosis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking anabolic steroids, oral corticosteroids, testosterone, or androgen supplements, you may need to stop as recent use of these is part of the exclusion criteria.
What data supports the effectiveness of the treatment Alanine, Alanine, L-Alanine, Essential amino acids for spinal stenosis?
Research shows that essential amino acids can help maintain muscle mass and strength, which is important for overall mobility and function. This suggests that amino acid supplementation might support muscle health in conditions like spinal stenosis, where maintaining muscle function is beneficial.12345
Is β-alanine supplementation safe for humans?
β-alanine supplementation is generally considered safe for humans, with paraesthesia (a tingling sensation) being the only reported side effect. Studies show no significant adverse effects on muscle taurine levels or clinical blood markers, and any increase in certain blood enzymes remains within normal ranges.678910
How does the treatment with β-alanine differ from other treatments for spinal stenosis?
The treatment with β-alanine is unique because it focuses on nutritional supplementation to potentially enhance muscle carnosine levels, which may improve muscle performance and buffering capacity. This approach is different from standard treatments for spinal stenosis, which typically involve physical therapy, pain management, or surgery.67111213
What is the purpose of this trial?
The goal of this clinical trial is to prospectively evaluate the effects of essential amino acid (EAA) supplementation on the volume and structure of the muscles surrounding the spine (paraspinal musculature). The main questions it aims to answer are:* Does EAA supplementation preserve paraspinal muscle volume (PMV) and influence changes to spinal alignment following lumbar spine surgery?* Does preserving paraspinal muscle volume (PMV) improve post-operative functional status?* Does preserving PMV reduce post-operative complications, pain, and opioid consumption?Participants will be asked to:* Consume either EAA supplement or placebo (alanine) twice daily for one week before and two weeks after lumbar spine surgery* Record pain levels and medication use in a diary* Perform functional assessments at routine follow-up visits after surgery* Undergo blood draws to monitor nutrition status and health* Undergo one spine magnetic resonance imaging (MRI) before surgery as part of routine surgical planning* Undergo one additional spine MRI after surgery to monitor PMV after treatmentResearchers will compare the group that consumed EAA supplement and the group that consumed placebo to see if there is a difference in paraspinal muscle volume changes and measures of spinal alignment, functional abilities, pain levels, and opioid use.
Eligibility Criteria
This trial is for individuals undergoing lumbar spine surgery due to spinal stenosis. Participants must be willing to take a nutritional supplement or placebo, keep a pain and medication diary, perform functional assessments, and have two MRIs. Those with certain health conditions that could interfere with the study may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants undergo baseline assessments and begin supplementation or placebo
Treatment
Participants consume EAA supplement or placebo for 1 week before and 2 weeks after surgery
Postoperative Follow-up
Participants are monitored for functional mobility, pain, and medication use
Long-term Follow-up
Participants are monitored for long-term outcomes up to 2 years postoperatively
Treatment Details
Interventions
- Alanine
- Essential amino acids
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
MEND
Collaborator