Status:
WITHDRAWN
Targeted Nutritional Supplement After Lumbar Spine Surgery: A Randomized, Placebo-Controlled, Double-Blind Trial
Lead Sponsor:
University of California, Irvine
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 musc...
Detailed Description
This study is a randomized, placebo-controlled, double-blinded, single-center clinical trial to elucidate the effects of perioperative essential amino acid nutritional supplementation in pursuit of th...
Eligibility Criteria
Inclusion
- 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
- 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 with anabolic steroids or oral corticosteroids for \>1 week
- History of chronic opioid consumption \> 6 months
- Testosterone or Androgen Supplementation
- History of major head trauma
- Pregnant/breastfeeding women
- History of dementia
- Vulnerable populations (minors, prisoners)
- Lack of decision making capacity
- BMI \<18 or \> 40
- HbA1c \> 7.0
- Patients with pacemakers
- Specific dietary restrictions or allergies that prevent the use of nutritional supplements or dietary modifications
- Currently enrolled in another clinical trial involving interventions that may interfere with the outcomes of this study.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06579391
Start Date
January 1 2025
End Date
July 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868