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

NCT06247813 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Inflammation Support Formula

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

DIETARY_SUPPLEMENT

Nerve Health Formula

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

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).

Sponsors & Collaborators

  • Ethos Research & Development

    lead INDUSTRY

Principal Investigators

  • Joshua Gunn, PhD · Ethos Research and Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2025-02-15
Completion
2025-07-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247813 on ClinicalTrials.gov