Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Ethos Research & Development
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Quantitative urine biomarker levels.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Joshua Gunn
Chief Science Officer
Ethos Research & Development
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.
Outcomes
Primary Outcomes
Quantitative urine biomarker levels.
Time Frame: 1 and 3 months of supplementation.
Quantitative urine biomarker levels after 1 and 3 months of supplementation.
Quality-of-life measures.
Time Frame: 1 month of supplementation, 3 months and at 3 month follow up.
Summary scores of quality-of-life measures, Short Form- 36 (SF-36); The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Coding of each item varies across the measure however all items are scored so that a high score defines a more favorable health state.
Secondary Outcomes
- Anxiety symptoms.(1 month, 2 months, 3 months and at 3 month follow up.)
- Visual Analog Scale pain scores(1 month, 2 months, 3 months and at 3 month follow up.)
- Depression symptoms.(1 month, 2 months, 3 months and at 3 month follow up.)
- Sleep quality score(1 month, 2 months, 3 months and at 3 month follow up.)
- Profile of Mood States(1 month, 2 months, 3 months and at 3 month follow up.)