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Targeted Nutritional Supplement After Lumbar Spine Surgery: A Randomized, Placebo-Controlled, Double-Blind Trial

NCT06579391 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-29

No results posted yet for this study

Summary

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 treatment

Researchers 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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DIETARY_SUPPLEMENT

Essential amino acids

Twice daily consumption for two weeks before and one week after surgery.

DIETARY_SUPPLEMENT

Alanine

Twice daily consumption for two weeks before and one week after surgery.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-12-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579391 on ClinicalTrials.gov