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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether essential amino acid (EAA) supplements can aid muscle recovery around the spine after lumbar spine surgery. Researchers aim to determine if EAA supplements can maintain muscle strength, enhance recovery, and reduce pain and opioid use post-surgery. Participants will receive either the EAA supplement, which includes alanine, or a placebo, and their muscle health and recovery will be monitored through various assessments. This trial targets individuals undergoing lumbar spine surgery who have not had previous back surgery and have tried other treatments without success. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential benefits of EAA supplements in surgical recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that essential amino acid (EAA) supplements are generally safe. These supplements can enhance muscle health and overall quality of life, particularly when they include leucine, a key essential amino acid. Some studies suggest that amino acid treatments might reduce chronic back pain and inflammation.

Although EAA supplements are mostly safe, they can occasionally cause minor and temporary side effects, such as an upset stomach or headaches. Following the directions is important to minimize any risks. Overall, EAAs have a good safety record when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for spinal stenosis focus on managing symptoms through medications like NSAIDs, physical therapy, or even surgery. However, these nutritional supplements are unique because they use essential amino acids (EAAs) like L-leucine and L-lysine to potentially support muscle health and recovery. Researchers are excited about these treatments because EAAs might boost the body's ability to repair and strengthen muscles around the spine, possibly improving outcomes after surgery. Unlike traditional approaches that mainly address pain, these supplements aim to enhance the body's natural healing processes, offering a fresh angle on spinal stenosis treatment.

What evidence suggests that essential amino acid supplementation might be an effective treatment for spinal stenosis?

Research has shown that essential amino acids (EAAs), which participants in this trial may receive, can help prevent muscle loss. One study found that people who took EAA supplements while on bed rest for 28 days lost less muscle. Maintaining muscle mass is important, as it might aid recovery after surgery. Some studies have found that similar supplements increased muscle strength, but they did not show improvements in pain or mobility. However, EAAs are believed to support muscle health, potentially aiding recovery from spinal surgery. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713956/

Amino Acid Supplementation May Help Prevent Muscle ... Three studies reported favorable mobility outcomes for patients receiving EAA. Meta-analysis was prohibited by variation in measurement and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943023001092

Branched-chain amino acids plus vitamin D ... BCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength increased.

3. londonspine.com londonspine.com/branched-chain-amino-acids-plus-vitamin-d-supplementation-promote-increased-muscle-strength-following-lumbar-surgery-for-lumbar-spinal-stenosis-a-randomized-trial-london-spine/

Branched-Chain Amino Acids Plus Vitamin D ... Conclusions: BCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength ...

4. researchgate.net researchgate.net/publication/369386792_Branched-chain_amino_acids_plus_vitamin_D_supplementation_promote_increased_muscle_strength_following_lumbar_surgery_for_lumbar_spinal_stenosis_a_randomized_trial

Branched-chain amino acids plus vitamin D ... Conclusions: BCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7931746/

Effect of Protein Supplement on Paraspinal Muscles in ... Paddon-Jones et al39 showed that essential amino acid supplementation decreased the loss of lean muscle mass during 28 days of bed rest.

6. journals.lww.com journals.lww.com/md-journal/fulltext/2024/05100/the_efficacy_and_safety_of_leucine_enriched.11.aspx

The efficacy and safety of leucine-enriched essential amino ... Supplementation with leucine-enriched proteins is safe and efficacious in the improvement of muscle density and quality of life.

7. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05854-5

Focusing on spinal stenosis: emerging discoveries concerning ... This study reveals an alendronate-spinal stenosis association, offering insights for clinical prevention. It also identifies new genetic drug targets.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5102273/

Reduction in Pain and Inflammation Associated With Chronic ... Treatment with amino acid precursors was associated with substantial improvement in chronic back pain, reduction in inflammation, and improvement in back pain.

9. painandspinespecialists.com painandspinespecialists.com/are-essential-amino-acid-supplements-safe/

Are Essential Amino Acid Supplements Safe? While essential amino acid supplement treatments are generally regarded as safe when used appropriately, some minor and temporary risks may be associated with ...