Recruiting
Phase 2

Dietary Supplementation

Sponsor:

Ethos Research & Development

Code:

NCT06247813

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Inflammation Support Formula

Nerve Health Formula

Redox Support Formula

Study Details

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

Study ID

NCT06247813

Start date

Feb 8, 2024

Status verified date

Sep, 2024

Completion date

Jul 30, 2025

Anticipated

Primary completion date

Feb 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nerve Health

experimental: Oxidative Stress

experimental: Inflammation

Interventions

Inflammation Support Formula

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

Nerve Health Formula

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

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).

Primary outcome measure

  • Quantitative urine biomarker levels. [ Time Frame: 1 and 3 months of supplementation. ]
  • Quality-of-life measures. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Brianna Krause, MS

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

Locations

Ethos Research and Development

Recruiting

Newport, Kentucky, United States, 41071

Contacts

Brianna Krause, MS

352-502-3854Brianna.Krause@ethosrd.com

Principal Investigator:

Joshua Gunn, PhD

More Information

Sponsor

Ethos Research & Development

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ethos Research & Development on 2024-09-19.