Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain

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Description

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.

Targeted Conditions

Study Overview

Start Date
February 1, 2024
Completion Date
July 30, 2025
Enrollment
75
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Ethos Research and Development
Newport, Kentucky 41071, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
75
Eligibility Criteria
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 Contact Info

Study Contact Name
Brianna Krause, MS
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06247813