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

NCT06579391 | Withdrawn DMC

• 1 other identifier: 2811
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Keywords

nutritional supplementation; essential amino acids; lumbar spine surgery; paraspinal muscle volume; paraspinal muscle fatty infiltration

Outcome Measures

Primary Outcomes (1)

• Paraspinal muscle volume

  Quantification of bilateral paraspinal muscle cross-sectional area in cm\^2 measured with Visage Imaging (San Diego, California) software by two experienced musculoskeletal radiologists marking the borders of these muscles at a standardized spinal level in the lumbar spine. Psoas muscle cross-sectional areas and body height will be used for standardization of body type. Intraclass correlation coefficient between observers will be evaluated and interpreted according to the following guidelines: 0-0.40 poor; 0.41-0.60, moderate; 0.61-0.80, good; and 0.81-1.00 excellent.

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

Secondary Outcomes (17)

• Percentage of paraspinal muscle fatty infiltration

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

• Paraspinal muscle qualitative fatty infiltration grading (simplified 3-tier classification)

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

• Sagittal spinopelvic alignment (angles measured in degrees)

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

• Low back pain (Oswestry disability index 2.1A, total score)

  Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.

• Health-related quality of life (36-Item Short Form Health Survey total and subsection scores)

  Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.

Study Arms (2)

Treatment

EXPERIMENTAL

One scoop (20 grams) of EAAs mixed in 10-12 ounces of a cold beverage to taste preference consumed orally twice daily between meals for 1 week before surgery up until 2 weeks after surgery. Active ingredients: L-leucine (3.6g), L-lysine as L-lysine HCl (3.2g), L-phenylalanine (3.2g), L-valine (2.4g), L-threonine (2.8g), L-isoleucine (2.0g), L-methionine (0.6g), and L-histidine as L-histidine HCl (2.2g)

Dietary Supplement: Essential amino acids

Placebo

PLACEBO COMPARATOR

One scoop (20 grams) of placebo mixed in 10-12 ounces of a cold beverage to taste preference consumed orally twice daily between meals for 1 week before surgery up until 2 weeks after surgery. Active ingredients: alanine

Dietary Supplement: Alanine

Interventions

Essential amino acids DIETARY_SUPPLEMENT

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

Treatment

Alanine DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Amino Acids, Essential; Alanine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Department of Orthopaedic Surgery

Model Details: This is a two-arm, randomized, placebo-controlled, double-blinded, single-center clinical trial.

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: August 30, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)