Clinical trial NCT06247813: Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
Official title: Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Lead sponsor: Ethos Research & Development
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Quantitative urine biomarker levels.
timeFrame: 1 and 3 months of supplementation.
measure: Quality-of-life measures.
timeFrame: 1 month of supplementation, 3 months and at 3 month follow up.
measure: Quality-of-life measures.
timeFrame: 1 month of supplementation, 3 months and at 3 month follow up.
Secondary outcomes:
measure: Visual Analog Scale pain scores
timeFrame: 1 month, 2 months, 3 months and at 3 month follow up.
measure: Depression symptoms.
timeFrame: 1 month, 2 months, 3 months and at 3 month follow up.
measure: Anxiety symptoms.
timeFrame: 1 month, 2 months, 3 months and at 3 month follow up.
measure: Sleep quality score
timeFrame: 1 month, 2 months, 3 months and at 3 month follow up.
measure: Profile of Mood States
timeFrame: 1 month, 2 months, 3 months and at 3 month follow up.
Other outcomes:
Locations:
city: Newport
country: United States
facility: Ethos Research and Development
state: Kentucky
Study officials:
affiliation: Ethos Research and Development
name: Joshua Gunn, PhD
role: PRINCIPAL_INVESTIGATOR
References: