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

Phase 2RecruitingNCT06247813

Ethos Research & Development75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Quantitative urine biomarker levels after 1 and 3 months of supplementation.

Time frame: 1 and 3 months of supplementation.

Quality-of-life measures.

Summary scores of quality-of-life measures, patient reported outcome measurement information system 29 (PROMIS-29); assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. For overall scoring of the test (i.e., adding each response) a higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function), meaning a worse outcome.

Time frame: 1 month of supplementation, 3 months and at 3 month follow up.

Quality-of-life measures.

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.

Time frame: 1 month of supplementation, 3 months and at 3 month follow up.

Secondary Outcomes

Visual Analog Scale pain scores

Visual Analog Scale (VAS) pain scores are asked with 4 questions, current pain, worst pain, least pain and average pain since the subjects last visit. The scale is 0 to 10 where 0 is "no pain" and 10 is "worst imaginable pain", 10 would indicate a worse outcome.