Dietary Supplements for Chronic Pain

Overseen By Joshua Gunn, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ethos Research & Development

Disqualifiers: Infection, Psychiatric disorder, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily nutritional supplements can improve life for individuals experiencing chronic pain lasting at least three months. Urine tests determine which supplement might work best for each participant, targeting stress reduction, nerve health improvement, or inflammation reduction. Participants will take one of these targeted supplements—Inflammation Support Formula, Nerve Health Formula, or Redox Support Formula—for three months to assess its impact on pain and overall quality of life. Ideal candidates have already submitted a urine sample for biomarker testing and are committed to following a supplement regimen. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the Inflammation Support Formula can help reduce inflammation and chronic pain. Studies have found it improves quality of life without causing major side effects. This formula includes ingredients like curcumin, known to manage pain with fewer side effects than traditional treatments.

For the Nerve Health Formula, data suggests it helps with pain from nerve damage, such as tingling or burning sensations. One study on nerve pain found that it effectively relieved symptoms without significant negative effects.

The Redox Support Formula is designed to address oxidative stress, which can be linked to chronic pain. Although more high-quality research is needed, current findings suggest it is safe to use. No evidence of severe side effects has been found, and it has not shown toxicity even with repeated use.

Overall, these formulas appear well-tolerated in humans, with no major adverse events reported. Since this trial is in Phase 2, earlier trials have already demonstrated some level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a novel approach to managing chronic pain by targeting oxidative stress, nerve health, and inflammation. Unlike the standard treatments, which often rely on pain relief medications and anti-inflammatory drugs, these formulas focus on supporting the body's natural systems. The Inflammation Support Formula aims to reduce inflammation at its source, the Nerve Health Formula enhances nerve function and repair, and the Redox Support Formula addresses oxidative stress, a key factor in chronic pain conditions. This multi-faceted approach could provide a more holistic and potentially safer alternative to conventional pain management strategies.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will evaluate the effectiveness of different dietary supplements for managing chronic pain. Participants will be assigned to one of the treatment arms: Inflammation Support Formula, Nerve Health Formula, or Redox Support Formula.

Research has shown that inflammation can significantly contribute to chronic pain. One study found that eating more foods that reduce inflammation helped lower stress and pain levels. Another study discovered that a special supplement containing polyphenols (beneficial plant compounds) eased pain in people with knee arthritis and improved their quality of life.

For nerve health, research found that a specific formula reduced pain and other symptoms in people with diabetic nerve issues. This formula worked better than a placebo (a fake treatment used for comparison).

Regarding redox support, which involves balancing cell damage from free radicals, research suggests that increasing antioxidant defenses might help reduce chronic inflammation and pain. Overall, these findings suggest that these supplements could help manage chronic pain by addressing inflammation, nerve health, and oxidative stress. ^{3 6 7 8 9}

Who Is on the Research Team?

Joshua Gunn, PhD

Principal Investigator

Ethos Research and Development

Are You a Good Fit for This Trial?

This clinical trial is for individuals suffering from chronic pain. Participants will be selected based on specific markers in their urine that indicate deficiencies related to their condition. The study excludes details not provided.

Inclusion Criteria

Previously submitted a urinary biomarker sample and agreed to be contacted for research

I have been experiencing chronic pain for 3 months or more.

I can take pills and follow a supplement plan.

Exclusion Criteria

I have had a bacterial or viral infection recently or within the last 3 months.

Pregnant or breast-feeding or have plans to become pregnant at any time during the study

Known sensitivity or allergy to any of the ingredients in the study products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biomarker-guided nutritional supplementation based on their specific urinary biomarker test results

3 months

Follow-up

Participants are monitored for changes in urinary biomarker levels and quality of life measures

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Inflammation Support Formula
• Nerve Health Formula
• Redox Support Formula

Trial Overview The study tests the effects of three dietary supplements designed to support inflammation, nerve health, and redox balance based on individual urinary biomarkers. It aims to improve quality of life over a 3-month period by tailoring supplementation to each person's needs.

How Is the Trial Designed?

Group I: Oxidative Stress Experimental Treatment 1 Intervention

Group II: Nerve Health Experimental Treatment 1 Intervention

Group III: Inflammation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ethos Research & Development

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

In a study involving 210 normoglycemic adults with idiopathic pain, alpha-lipoic acid (ALA) supplementation (400 mg/day and 800 mg/day) significantly reduced pain levels as measured by the numerical rating scale (NRS) and visual analogue scale (VAS) after 2 months, while the placebo group showed no improvement.

ALA was found to be safe, with no reported adverse effects or changes in blood glucose levels, suggesting it could be a viable alternative for managing idiopathic pain compared to traditional analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial. Esposito, C., Ugo Garzarella, E., Santarcangelo, C., et al.[2022]

Methylene blue (MB) significantly reduced pain levels in patients with chronic refractory neuropathic pain, showing a notable decrease in the Numerical Rating Scale scores at 60 minutes post-infusion and on the following days.

The infusion of MB also led to a decrease in prolactin levels, suggesting a potential endocrine effect, although the specific role of prolactin in neuropathic pain management remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the protein biomarkers and the analgesic response to systemic methylene blue in patients with refractory neuropathic pain: a double-blind, controlled study. Miclescu, AA., Svahn, M., Gordh, TE.[2020]

NCX 2057 effectively reduces pain in models of both inflammatory and neuropathic pain, showing significant improvements in pain thresholds in rats and mice, indicating its potential as a pain relief treatment.

The compound works by inhibiting cyclooxygenase (COX-1 and COX-2) activities and has unique properties due to its combination of nitric oxide release and antioxidant effects, which are not seen with standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NCX 2057, a novel NO-releasing derivative of ferulic acid, suppresses inflammatory and nociceptive responses in in vitro and in vivo models. Ronchetti, D., Borghi, V., Gaitan, G., et al.[2021]

Resveratrol, a dietary antioxidant, effectively reduces inflammatory hyperalgesia in rats by modulating reactive oxygen species (ROS) levels and regulating antioxidant enzyme activities during both early and late phases of hyperalgesia.

The study found that resveratrol downregulates the ERK signaling pathway associated with pain, suggesting a potential mechanism for its anti-hyperalgesic effects, while the TNFR1 levels remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resveratrol alleviates inflammatory hyperalgesia by modulation of reactive oxygen species (ROS), antioxidant enzymes and ERK activation. Singh, AK., Vinayak, M.[2018]

Administering an Nrf2 antibody after sciatic nerve injury significantly reduced thermal allodynia (pain sensitivity) in young mice, indicating a potential therapeutic effect in managing pain following nerve injuries.

The Nrf2 antibody treatment also led to decreased levels of phosphorylated ERK and the apoptotic protein Bcl-6 in dorsal root ganglion neurons, suggesting that targeting the Nrf2 pathway may help protect against nerve injury-induced pain and cellular damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nuclear factor erythroid 2-related factor 2 antibody attenuates thermal hyperalgesia in the dorsal root ganglion: Neurochemical changes and behavioral studies after sciatic nerve-pinch injury. Xiang, Q., Yu, C., Zhu, YF., et al.[2017]

RedoxPRF is a novel treatment that can be applied transcutaneously to reduce oxidative stress and inflammation, potentially benefiting patients with chronic pain and inflammatory conditions.

The proposed mechanism of action for RedoxPRF involves reducing free radicals and restoring redox balance, which may offer a new approach to treating inflammatory diseases and chronic pain, distinct from traditional methods like ablation or stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anti-Inflammatory Action of Pulsed Radiofrequency-A Hypothesis and Potential Applications. Sluijter, ME., Teixeira, A., Vissers, K., et al.[2023]

A review of 847 studies found that a low-carbohydrate or ketogenic diet significantly improved neurological outcomes in 83% of cases, suggesting potential benefits for nervous system function.

Additionally, 71% of studies reporting on inflammatory biomarkers indicated a reduction in inflammation, highlighting the diet's potential to alleviate chronic pain associated with nervous system sensitization and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate and ketogenic diets: a scoping review of neurological and inflammatory outcomes in human studies and their relevance to chronic pain. Field, R., Field, T., Pourkazemi, F., et al.[2023]

In a 9-week double-blind placebo-controlled trial with 30 healthy runners, supplementation with AmLexin significantly reduced post-exercise muscle pain and oxidative stress compared to a placebo, particularly in the days following a half-marathon.

AmLexin demonstrated rapid benefits, showing lower levels of muscle soreness and higher antioxidant capacity within just 1-6 days after intense exercise, suggesting it could be a safe and effective option for managing delayed onset muscle soreness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AmLexin, a Standardized blend of Acacia catechu and Morus alba, shows benefits to delayed onset muscle soreness in healthy runners. Yimam, M., Talbott, SM., Talbott, JA., et al.[2020]

Luteolin (LUT) treatment significantly improved anxiety and depressive-like symptoms in animals with chronic neuropathic pain, indicating its potential as a therapeutic agent for mood disorders associated with chronic pain.

The study demonstrated that LUT works by regulating oxidative stress, neurotrophic factors, and neuroinflammation in the brain, reversing the negative changes caused by chronic pain, as evidenced by molecular and histopathological analyses after 21 days of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential anxiolytic and antidepressant-like effects of luteolin in a chronic constriction injury rat model of neuropathic pain: Role of oxidative stress, neurotrophins, and inflammatory factors. Mokhtari, T., Lu, M., El-Kenawy, AE.[2023]

Nutritional phenolics found in natural dietary compounds have been linked to a reduced risk of inflammation, which is important for preventing age-related diseases.

The review highlights the potential of phenolic compounds, such as those from the Lippia genus, as effective anti-inflammatory ingredients in functional foods and nutraceuticals, responding to the growing consumer demand for health-promoting products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Ingredients based on Nutritional Phenolics. A Case Study against Inflammation: Lippia Genus. Leyva-Jiménez, FJ., Lozano-Sánchez, J., Cádiz-Gurrea, ML., et al.[2023]

In a double-blind, placebo-controlled trial involving 59 participants with diabetic neuropathic pain, the Nerve Support Formula NeuropAWAY® significantly reduced pain intensity by 61.32% after 42 days compared to a slight increase in the placebo group.

The study also showed significant improvements in secondary outcomes, including nerve conduction velocity and other sensory symptoms, indicating the formula's potential effectiveness in managing diabetic peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of a Nerve Support Formula on Neuropathic Pain in Individuals Suffering from Type II Diabetes Mellitus. Cross, W., Srivastava, S.[2023]

A systematic review of 234 randomized placebo trials involving 10,525 patients found that placebo interventions generally do not have clinically important effects across various health conditions, with a pooled effect size indicating minimal benefit.

However, placebo interventions showed some influence on patient-reported outcomes, particularly for pain and nausea, although the effects varied widely and were often difficult to separate from reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. Hróbjartsson, A., Gøtzsche, PC.[2022]

Neuropathic pain (NP) is a chronic condition linked to nervous system damage, and current treatments often fall short, highlighting the need for new therapies.

Emerging strategies targeting neuroinflammation and oxidative stress, such as specialized pro-resolving mediators (SPMs) and NADPH oxidase inhibitors, show promise in improving NP treatment efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroinflammation, oxidative stress and their interplay in neuropathic pain: Focus on specialized pro-resolving mediators and NADPH oxidase inhibitors as potential therapeutic strategies. Teixeira-Santos, L., Albino-Teixeira, A., Pinho, D.[2021]

Citations

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Exploring the association between dietary Inflammatory ... This cross-sectional study explored the association between Dietary Inflammatory Index (DII) and chronic pain among 2581 American adults from NHANES data.

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Clinical evidence construction of East Asian herbal ... According to the meta-analysis, EAHM had a significantly superior effect on continuous pain intensity, tender joint count, and response rate. Patients treated ...

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Towards an Effective and Safe Treatment of Inflammatory Pain The clinical management of inflammatory pain requires an optimal balance between effective analgesia and associated safety risks.

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The effect of an anti-inflammatory diet on chronic pain We found a correlation between increased anti-inflammatory food intake and improved physical characteristics, stress, and pain in the patients we assessed.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023073516

A standardized nutraceutical supplement contributes to ... Our standardized polyphenol supplement alleviated pain in knee osteoarthritis. Pain relief was accompanied with quality of life improvement.

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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.

7. physiciansresearch.ca physiciansresearch.ca/products/inflammation-support-npn-80069064

Inflammation Support + 90 Vcap INFLAMMATION SUPPORT + by PHYSICIANS RESEARCH is a complex phytonutrient blend formulated to positively modulate the inflammatory response.

8. drcpainmd.com drcpainmd.com/inflammation-chronic-pain-and-the-power-of-curcumin/

Inflammation, Chronic Pain, and the Power of Curcumin A growing body of research suggests curcumin can reduce inflammation and help manage chronic pain — with fewer side effects than traditional anti-inflammatories ...

9. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04283-4

GAUDI study | Journal of Translational Medicine Our results do not support a long-lasting residual effect of SPMs consumption on chronic pain 12 weeks after the completion of treatment, ...