RecruitingPhase 2NCT06247813

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

Sponsor

Ethos Research & Development

Enrollment

75 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria6

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.

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Interventions

DIETARY_SUPPLEMENTInflammation Support Formula

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

DIETARY_SUPPLEMENTNerve Health Formula

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

DIETARY_SUPPLEMENTRedox 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).