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Nutritional Supplementation for Spinal Stenosis

SH
AS
Overseen ByAbhinav Sharma, MD

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking anabolic steroids, oral corticosteroids, testosterone, or androgen supplements, you may need to stop as recent use of these is part of the exclusion criteria.

What data supports the effectiveness of the treatment Alanine, Alanine, L-Alanine, Essential amino acids for spinal stenosis?

Research shows that essential amino acids can help maintain muscle mass and strength, which is important for overall mobility and function. This suggests that amino acid supplementation might support muscle health in conditions like spinal stenosis, where maintaining muscle function is beneficial.12345

Is β-alanine supplementation safe for humans?

β-alanine supplementation is generally considered safe for humans, with paraesthesia (a tingling sensation) being the only reported side effect. Studies show no significant adverse effects on muscle taurine levels or clinical blood markers, and any increase in certain blood enzymes remains within normal ranges.678910

How does the treatment with β-alanine differ from other treatments for spinal stenosis?

The treatment with β-alanine is unique because it focuses on nutritional supplementation to potentially enhance muscle carnosine levels, which may improve muscle performance and buffering capacity. This approach is different from standard treatments for spinal stenosis, which typically involve physical therapy, pain management, or surgery.67111213

What is the purpose of this trial?

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 treatmentResearchers 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.

Eligibility Criteria

This trial is for individuals undergoing lumbar spine surgery due to spinal stenosis. Participants must be willing to take a nutritional supplement or placebo, keep a pain and medication diary, perform functional assessments, and have two MRIs. Those with certain health conditions that could interfere with the study may not qualify.

Inclusion Criteria

I need surgery for my lower back problem and haven't had back surgery before.
My condition did not improve with basic treatments.

Exclusion Criteria

BMI less than 18 or greater than 40
I don't have conditions like PKU, galactosemia, or nephrotic syndrome that affect nutrition.
I have taken supplements for protein or calorie needs before.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 months to 6 weeks
1 visit (in-person)

Preoperative

Participants undergo baseline assessments and begin supplementation or placebo

6 weeks to 1 week
1 visit (in-person)

Treatment

Participants consume EAA supplement or placebo for 1 week before and 2 weeks after surgery

3 weeks
Daily consumption, 1 surgery visit, inpatient stay

Postoperative Follow-up

Participants are monitored for functional mobility, pain, and medication use

12 weeks
Follow-up visits at 2, 6-8, and 12 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes up to 2 years postoperatively

Up to 2 years

Treatment Details

Interventions

  • Alanine
  • Essential amino acids
Trial Overview The trial is testing if taking essential amino acids (EAA) can help maintain muscle volume around the spine after surgery, which might improve recovery and reduce complications like pain or opioid use. Patients will randomly receive either EAA or a placebo (alanine) before and after their surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
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)
Group II: PlaceboPlacebo Group1 Intervention
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

MEND

Collaborator

Trials
2
Recruited
150+

Findings from Research

Sarcopenia, a condition that increases the risk of falls and fractures in individuals over 50, can be mitigated through healthy lifestyle changes, particularly adequate dietary protein and vitamin D intake, along with regular exercise.
Optimal dietary protein intake is recommended at 1.0-1.2 g/kg body weight per day, combined with 800 IU of vitamin D daily, and engaging in physical activity 3-5 times a week to enhance muscle mass and strength effectively.
Nutrition and Sarcopenia.Rizzoli, R.[2015]
Insufficient protein intake can lead to muscle loss and functional decline, especially in older adults, particularly during periods of inactivity like hospitalization.
Supplementing with approximately 30 grams of protein and 3 grams of leucine can help stimulate muscle protein synthesis in older adults, potentially improving muscle health during times of reduced activity.
The importance of dietary protein for muscle health in inactive, hospitalized older adults.Thalacker-Mercer, AE., Drummond, MJ.[2018]
In a study of 39 older adults undergoing total knee arthroplasty, perioperative supplementation with essential amino acids (EAA) significantly reduced muscle atrophy in both the quadriceps and hamstrings compared to a placebo, indicating its efficacy in preserving muscle volume during recovery.
The EAA supplementation was found to be safe for older adults, with no significant differences in blood chemistry values between the EAA and placebo groups, suggesting it can be a beneficial addition to postoperative care.
Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.Dreyer, HC., Owen, EC., Strycker, LA., et al.[2022]

References

Nutrition and Sarcopenia. [2015]
The importance of dietary protein for muscle health in inactive, hospitalized older adults. [2018]
Effect of amino acid supplementation on muscle mass, strength and physical function in elderly. [2021]
Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2022]
Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial. [2022]
24-Week β-alanine ingestion does not affect muscle taurine or clinical blood parameters in healthy males. [2020]
A Systematic Risk Assessment and Meta-Analysis on the Use of Oral β-Alanine Supplementation. [2023]
The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. [2023]
The Safety and Regulatory Process for Amino Acids in Europe and the United States. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The safety of oral use of L-glutamine in middle-aged and elderly individuals. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
β-Alanine dose for maintaining moderately elevated muscle carnosine levels. [2014]
Effects of beta-alanine on muscle carnosine and exercise performance: a review of the current literature. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
No Effect of β-alanine on Muscle Function and Kayak Performance. [2018]
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