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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Previously submitted a urinary biomarker sample and agreed to be contacted for research. - Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months. - Be able to take oral medication and/or be willing to adhere to the supplement regimen.

Exclusion Criteria

  • Diagnosis of bacterial or viral infection during or 3 months prior to the study. - Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit. - A history of cancer within 5 years prior to screening visit. - Be pregnant or breast-feeding or have plans to become pregnant at any time during the study - Participant has a known sensitivity or allergy to any of the ingredients in the study products. - Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nerve Health
  • Dietary Supplement: Nerve Health Formula
    Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
Experimental
Oxidative Stress
  • Dietary Supplement: Redox Support Formula
    N-Acetyl-L-Cysteine (500mg), CoQ10 (250mg), Acetyl-L-Carnitine (200mg), Alpha Lipoic Acid (200mg), Benfotiamine (300mg), Selenium (250mcg), Riboflavin (50mg), Zinc (15mg) and Copper (1.8mg).
Experimental
Inflammation
  • Dietary Supplement: Inflammation Support Formula
    Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).

Recruiting Locations

Ethos Research and Development
Newport, Kentucky 41071
Contact:
Brianna Krause, MS
352-502-3854
Brianna.Krause@ethosrd.com

More Details

Status
Recruiting
Sponsor
Ethos Research & Development

Study Contact

Brianna Krause, MS
‪(513) 400-3057‬
brianna.krause@ethosrd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.