RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-08
Study Completion:2025-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06247813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previously submitted a urinary biomarker sample and agreed to be contacted for research.
  2. * Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months.
  3. * Be able to take oral medication and/or be willing to adhere to the supplement regimen.
  1. * Diagnosis of bacterial or viral infection during or 3 months prior to the study.
  2. * Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit.
  3. * A history of cancer within 5 years prior to screening visit.
  4. * Be pregnant or breast-feeding or have plans to become pregnant at any time during the study
  5. * Participant has a known sensitivity or allergy to any of the ingredients in the study products.
  6. * Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.

Contacts and Locations

Study Contact

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

Principal Investigator

Joshua Gunn, PhD
PRINCIPAL_INVESTIGATOR
Ethos Research and Development

Study Locations (Sites)

Ethos Research and Development
Newport, Kentucky, 41071
United States

Collaborators and Investigators

Sponsor: Ethos Research & Development

  • Joshua Gunn, PhD, PRINCIPAL_INVESTIGATOR, Ethos Research and Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-08
Study Completion Date2025-07-30

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain