Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inflammation Support Formula, Nerve Health Formula, Redox Support Formula.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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).
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- Visual Analog Scale pain scores [Time frame: 1 month, 2 months, 3 months and at 3 month follow up.]
- Depression symptoms. [Time frame: 1 month, 2 months, 3 months and at 3 month follow up.]
- Anxiety symptoms. [Time frame: 1 month, 2 months, 3 months and at 3 month follow up.]
- Sleep quality score [Time frame: 1 month, 2 months, 3 months and at 3 month follow up.]
- Profile of Mood States [Time frame: 1 month, 2 months, 3 months and at 3 month follow up.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Ethos Research and Development — Newport
Identifiers
NCT: NCT06247813 · 23-02-637-1557