WithdrawnNot Applicable

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

Stopped: Institutional barriers.

United States0Started 2025-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of lumbar pathology requiring lumbar spine surgery without previous surgical intervention * Failure of more conservative treatment options * If undergoing fusion, surgery consists of short segment fusion of less than or equal to 5 levels without staged surgery * Provided voluntary written informed consent to participate in the study * Able to comply with all study procedures, including taking the assigned treatment or placebo as instructed and attending follow-up visits * No restrictions on the use of nutritional supplements or dietary modifications * Able to complete self-report questionnaires and assessments as required by the study protocol * Confirmed ambulatory status prior to surgery Exclusion Criteria: * Comorbidities excluding the use of the proposed nutritional supplement or resulting in decreased serum albumin levels (phenylketonuria, galactosemia, nephrotic syndrome) * Diagnosis other than lumbar spine pathology requiring lumbar spine surgery * Non-ambulatory status * Uncontrolled endocrine disease; heart, kidney, liver, blood, or respiratory disease; peripheral vascular disease * Unable or unwilling to comply with study procedures, including taking the assigned treatment or placebo as instructed and attending follow-up visits. * History of congenital metabolic disease (e.g Hartnup disease, Phenylketonuria) * Active cancer * Active infection * Prior protein-calorie supplementation for other clinical indications * Recent treatment …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Paraspinal muscle volume

Timeframe: Preoperative lumbar MRI at 6 months-6 weeks prior to surgery, postoperative lumbar MRI at 8-10 weeks after surgery.

Trial details

NCT IDNCT06579391

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials