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
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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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2024-02-08
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Nerve Health
Nerve Health Formula
Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
Oxidative Stress
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).
Inflammation
Inflammation Support Formula
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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Ethos Research & Development
INDUSTRY
Responsible Party
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Joshua Gunn
Chief Science Officer
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
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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23-02-637-1557
Identifier Type: -
Identifier Source: org_study_id
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