Targeted Nutritional Supplement After Lumbar Spine Surgery: A Randomized, Placebo-Controlled, Double-Blind Trial
NCT Number: NCT06579391
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Spinal Stenosis
Interventions: DIETARY_SUPPLEMENT: Essential amino acids|DIETARY_SUPPLEMENT: Alanine
Sponsor: University of California, Irvine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-07
Locations: University of California Irvine Medical Center, Orange, California, 92868, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Percentage of paraspinal muscle fatty infiltration, Quantification of the proportion of fat to total paraspinal muscle cross-sectional area on MRI proton density fat fraction in ImageJ (National Institutes of Health) by two experienced musculoskeletal radiologists marking the borders of these muscles at a standardized spinal level in the lumbar spine. 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.|Paraspinal muscle qualitative fatty infiltration grading (simplified 3-tier classification), Qualitative rating of paraspinal muscle fatty infiltration by two experienced musculoskeletal radiologists using MRI proton density fat fraction on Visage Imaging (San Diego, California) software. Visual scale modified from the Goutallier grading system: 0 = \<10% fat, 1 = \<50% fat, 2 = \>50% fat. 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.|Sagittal spinopelvic alignment (angles measured in degrees), Radiographic measurements of sagittal vertical axis, pelvic incidence, lumbar lordosis, and pelvic tilt on Visage Imaging (San Diego, California) software. 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.|Low back pain (Oswestry disability index 2.1A, total score), Validated, 10-item questionnaire for self-reported low back pain and limitations when performing daily activities., 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), Validated, 36-item questionnaire for self-reported quality of life across 8 subsection domains: general health, physical functioning, role physical, role emotional, social functioning, mental health, bodily pain, and vitality., Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.|Self-reported capability to perform activities (PROMIS Physical Function total score), Validated questionnaire assessing physical capability to perform activities of daily living and other more strenuous tasks., Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.|Self-reported perceived problems (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) total and subsection scores), Validated questionnaire assessing self-reported perceived problems across 5 health state dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression., Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.|6-minute walk test (distance in meters), Assessment of cardiopulmonary function and aerobic endurance measured as the distance covered over a 6-minute time frame., Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.|5 repetitive sit-to-stand (time in seconds), Assessment of lower extremity functional strength, transitional movements, and balance through timed repetitive sit to stand., Baseline visit (6 weeks-1 week preoperatively) and 2-week, 6-week, and 12-week follow up visits.|Hospital length of stay (time in days), Time from hospital admission for surgical intervention to discharge., Day of surgery until date of discharge|Incidence of postoperative complications (number of occurrences), Occurrence of postoperative complications including: surgical site infection, unplanned reoperation, mortality, cardiovascular events, thromboembolism, pneumonia, urinary tract infection, etc., Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.|Self-reported pain levels (Numeric Pain Rating Scale), Self-recorded pain levels at the time of supplement consumption and at the time of pain medication consumption in a pain diary., Daily recordings starting 1 week prior to surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.|Clinician-administered pain rating (Visual Analog Scale pain score), Clinician-administered patient pain rating., Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.|Patient-reported pain medication use (measured in mean morphine equivalents), Self-recorded pain medication consumption in a pain diary., Starting 1 week prior to surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.|Prescription opioid consumption (measured in mean morphine equivalents), Opioid medication dispensation through clinician monitoring of state controlled substances database (CURES)., Baseline visit (6 weeks-1 week preoperatively), immediately preoperative on day of surgery, and 2-week, 6-week, and 12-week follow up visits.|Time to opioid discontinuation (time in days), Time from date of surgery to last use of opioids listed in the self-reported pain diary., Day of surgery up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.|Time to less than baseline opioid consumption (time in days), Time to postoperative opioid consumption in mean morphine equivalents less than that measured at baseline (6 weeks to 1 week preoperatively) to day before surgery using the self-reported pain diary., Baseline visit (6 weeks-1 week preoperatively) up until 2 weeks after surgery or until time of opioid medication discontinuation for a maximum of 1 month after surgery, whichever is sooner.