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

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. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Inflammation Support Formula, Nerve Health Formula, Redox Support Formula, Redox Support Formula for chronic pain?

Research suggests that components similar to those in the treatment, like specialized pro-resolving mediators and NADPH oxidase inhibitors, can help reduce inflammation and oxidative stress, which are linked to chronic pain. Additionally, luteolin, a compound with antioxidant and anti-inflammatory properties, has shown potential in reducing pain and mood disorders in animal studies. ^{1 2 3 4 5}

Is the Dietary Supplements for Chronic Pain treatment generally safe for humans?

The research articles provided do not contain specific safety data for the dietary supplements mentioned under the names Inflammation Support Formula, Nerve Health Formula, or Redox Support Formula. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the Inflammation Support Formula, Nerve Health Formula, and Redox Support Formula treatment differ from other treatments for chronic pain?

This treatment is unique because it combines dietary supplements that may target inflammation and nerve health, potentially offering a novel approach by addressing oxidative stress and inflammation, which are key factors in chronic pain. Unlike standard pain medications, this treatment may work by supporting the body's natural processes to reduce inflammation and improve nerve function. ^{2 6 11 12 13}

What is the purpose of this trial?

The goal of this study is to use pain-specific urine biomarkers to evaluate how daily nutritional supplementation with biomarker guided formulas effect, quality of life and urinary biomarker scores in chronic pain patients. Assessing the effect of biomarker guided supplementation on pain specific biomarkers through changes in urinary biomarker scores may solidify the necessity for identifying deficiencies to create an individualized treatment plan for pain patients. This study aims to evaluate the effect of biomarker-guided supplementation on the three categories of urinary biomarkers using targeted ingredients specifically designed for oxidative stress, inflammation, and nerve health. This study provides subjects with one of three nutritional supplement formulas based on their specific urinary biomarker test results and assesses changes in their urinary biomarker levels and their quality of life as it relates to their pain over a 3-month period.

Research Team

Joshua Gunn, PhD

Principal Investigator

Ethos Research and Development

Eligibility Criteria

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.

Any dietary restriction that prevents the participant from consuming any of the ingredients in the study products

I have not been hospitalized for psychiatric reasons in the past year.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. New Zealand 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. [2023]

2. Netherlands 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. [2021]

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

Placebo interventions for all clinical conditions. [2022]

4. Netherlands 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. [2023]

5. New Zealand 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Anti-Inflammatory Action of Pulsed Radiofrequency-A Hypothesis and Potential Applications. [2023]

7. Korea (South) 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. [2020]

8. England 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. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Functional Ingredients based on Nutritional Phenolics. A Case Study against Inflammation: Lippia Genus. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

11. England 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. [2023]

12. France 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. [2022]

13. Netherlands 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. [2017]