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

NCT06247813 | Recruiting Phase 2

• 1 other identifier: 23-02-637-1557
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Quantitative urine biomarker levels.

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

  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.

  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.

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

Secondary Outcomes (5)

• 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.

• Anxiety 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.

Study Arms (3)

Nerve Health

EXPERIMENTAL

Dietary Supplement: Nerve Health Formula

Oxidative Stress

EXPERIMENTAL

Dietary Supplement: Redox Support Formula

Inflammation

EXPERIMENTAL

Dietary Supplement: Inflammation Support Formula

Interventions

Inflammation Support Formula DIETARY_SUPPLEMENT

Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).

Inflammation

Nerve Health Formula DIETARY_SUPPLEMENT

Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).

Nerve Health

Redox Support Formula DIETARY_SUPPLEMENT

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).

Oxidative Stress

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethos Research & Development: lead

Study Sites (1)

Ethos Research and Development

Newport, Kentucky, 41071, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Gunn, PhD

  Ethos Research and Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna Krause, MS

CONTACT

‪(513) 400-3057‬; brianna.krause@ethosrd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 8, 2024
• Study Start: February 8, 2024
• Primary Completion: February 15, 2025
• Study Completion: July 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)