Nutritional Supplementation for Spinal Stenosis

Overseen By Abhinav Sharma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Anabolic steroids, Corticosteroids, Opioids, Testosterone

Disqualifiers: Cancer, Infection, Endocrine disease, others

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 7 11 12 13}

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 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.

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.

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

Group I: Treatment Experimental Treatment 1 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: Placebo Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 400 adults with pelvic and extremity fractures, those who received conditionally essential amino acid (CEAA) supplementation experienced significantly fewer complications (30.5% vs. 43.8%) compared to the control group, indicating a protective effect of CEAA against postoperative issues.

CEAA supplementation helped maintain fat-free mass (FFM) at 6 weeks post-surgery, with a decrease of only -0.33 kg in the CEAA group compared to -0.9 kg in the control group, suggesting it may prevent early muscle wasting after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial. Hendrickson, NR., Davison, J., Glass, NA., et al.[2022]

The increasing use of amino acids from various sources necessitates thorough safety assessments due to the potential for high intake levels that exceed normal dietary amounts.

Establishing reliable Tolerable Upper Intake Levels (ULs) for amino acids is challenging due to insufficient toxicity studies and lack of clinical data, highlighting the need for comprehensive safety evaluations that include quality specifications and potential interactions with medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. Oketch-Rabah, HA., Roe, AL., Gurley, BJ., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nutrition and Sarcopenia. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

The importance of dietary protein for muscle health in inactive, hospitalized older adults. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effect of amino acid supplementation on muscle mass, strength and physical function in elderly. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

24-Week β-alanine ingestion does not affect muscle taurine or clinical blood parameters in healthy males. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Systematic Risk Assessment and Meta-Analysis on the Use of Oral β-Alanine Supplementation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Safety and Regulatory Process for Amino Acids in Europe and the United States. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The safety of oral use of L-glutamine in middle-aged and elderly individuals. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

β-Alanine dose for maintaining moderately elevated muscle carnosine levels. [2014]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of beta-alanine on muscle carnosine and exercise performance: a review of the current literature. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

No Effect of β-alanine on Muscle Function and Kayak Performance. [2018]