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

September 11, 2024 updated by: Joshua Gunn, Ethos Research & Development
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Newport, Kentucky, United States, 41071
        • Recruiting
        • Ethos Research and Development
        • Contact:
        • Principal Investigator:
          • Joshua Gunn, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve Health
Dietary supplement: Nerve Health Formula
Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
Experimental: Oxidative Stress
Dietary supplement: Redox Support Formula
N-Acetyl-L-Cysteine (500mg), CoQ10 (250mg), Acetyl-L-Carnitine (200mg), Alpha Lipoic Acid (200mg), Benfotiamine (300mg), Selenium (250mcg), Riboflavin (50mg), Zinc (15mg) and Copper (1.8mg).
Experimental: Inflammation
Dietary supplement: Inflammation Support Formula
Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative urine biomarker levels.
Time Frame: 1 and 3 months of supplementation.
Quantitative urine biomarker levels after 1 and 3 months of supplementation.
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, 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.
1 month of supplementation, 3 months and at 3 month follow up.
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.
1 month of supplementation, 3 months and at 3 month follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale pain scores
Time Frame: 1 month, 2 months, 3 months and at 3 month follow up.
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.
1 month, 2 months, 3 months and at 3 month follow up.
Depression symptoms.
Time Frame: 1 month, 2 months, 3 months and at 3 month follow up.
Percentage of subjects with a decrease in depression symptoms.
1 month, 2 months, 3 months and at 3 month follow up.
Anxiety symptoms.
Time Frame: 1 month, 2 months, 3 months and at 3 month follow up.
Percentage of subjects with a decrease in anxiety symptoms.
1 month, 2 months, 3 months and at 3 month follow up.
Sleep quality score
Time Frame: 1 month, 2 months, 3 months and at 3 month follow up.
Sleep quality (Pittsburg Sleep Quality Index (PSQI)) score (and subscale scores). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.17 The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
1 month, 2 months, 3 months and at 3 month follow up.
Profile of Mood States
Time Frame: 1 month, 2 months, 3 months and at 3 month follow up.
Profile of Mood States (POMS) score (and subscale scores). The POMS is a 40 item questionnaire assessing mood. The scale is a 5 point scale ranging from "Not at All" (0), "A Little" (1), "Moderately" (2), or "Quite a Lot" (3) or "Extremely" (4). Scores for the seven subscales are calculated by summing the numerical ratings for items that contribute to each subscale. Two of the items on the Esteem-related Affect (ERA) subscale are reverse-scored prior to being combined with the other items. They are all added or subtracted based on the subscale (TMD = [TEN+DEP+ANG+FAT+CON] - [VIG+ERA]. ) to obtain total mood disturbance. A higher score would indicate a negative outcome.
1 month, 2 months, 3 months and at 3 month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethos Research & Development

Investigators

  • Principal Investigator: Joshua Gunn, PhD, 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 Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-02-637-1557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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