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

NCT ID: NCT06247813

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nerve Health

Group Type EXPERIMENTAL

Nerve Health Formula

Intervention Type DIETARY_SUPPLEMENT

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

Oxidative Stress

Group Type EXPERIMENTAL

Redox Support Formula

Intervention Type 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).

Inflammation

Group Type EXPERIMENTAL

Inflammation Support Formula

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Inflammation Support Formula

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

Intervention Type DIETARY_SUPPLEMENT

Nerve Health Formula

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

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ethos Research & Development

INDUSTRY

Sponsor Role lead

Responsible Party

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Joshua Gunn

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Gunn, PhD

Role: PRINCIPAL_INVESTIGATOR

Ethos Research and Development

Locations

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Ethos Research and Development

Newport, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brianna Krause, MS

Role: CONTACT

‪(513) 400-3057‬

Facility Contacts

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Brianna Krause, MS

Role: primary

352-502-3854

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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23-02-637-1557

Identifier Type: -

Identifier Source: org_study_id

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