Chronic PainPhase 2NCT06247813
Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
A Phase 2 study testing Inflammation Support Formula, Nerve Health Formula and Redox Support Formula in people with Chronic Pain, run by Ethos Research & Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Inflammation Support Formula, Nerve Health Formula and Redox Support Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ethos Research and Development
Newport, Kentucky, 41071
Brianna Krause, MS, 352-502-3854, Brianna.Krause@ethosrd.com
Joshua Gunn, PhD
About this study
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
- Being tested
- Inflammation Support Formula, Nerve Health Formula, Redox Support Formula
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammation Support FormulaDietary supplement
Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).
Nerve Health FormulaDietary supplement
Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
Redox Support FormulaDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Nerve Health | Experimental | Not described Receives: Dietary Supplement: Nerve Health Formula |
| Oxidative Stress | Experimental | Not described Receives: Dietary Supplement: Redox Support Formula |
| Inflammation | Experimental | Not described Receives: Dietary Supplement: Inflammation Support Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative urine biomarker levels.
Quantitative urine biomarker levels after 1 and 3 months of supplementation.
Measured: 1 and 3 months of supplementation.
Quality-of-life measures.
Summary scores of quality-of-life measures, patient reported outcome measurement information system 29 (PROMIS-29); assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. For overall scoring of the test (i.e., adding each response) a higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function), meaning a worse outcome.
Measured: 1 month of supplementation, 3 months and at 3 month follow up.
Quality-of-life measures.
Summary scores of quality-of-life measures, Short Form- 36 (SF-36); The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Coding of each item varies across the measure however all items are scored so that a high score defines a more favorable health state.
Measured: 1 month of supplementation, 3 months and at 3 month follow up.
Secondary outcomes (5)
Visual Analog Scale pain scores
Visual Analog Scale (VAS) pain scores are asked with 4 questions, current pain, worst pain, least pain and average pain since the subjects last visit. The scale is 0 to 10 where 0 is "no pain" and 10 is "worst imaginable pain", 10 would indicate a worse outcome.
Measured: 1 month, 2 months, 3 months and at 3 month follow up.
Depression symptoms.
Percentage of subjects with a decrease in depression symptoms.
Measured: 1 month, 2 months, 3 months and at 3 month follow up.
Anxiety symptoms.
Percentage of subjects with a decrease in anxiety symptoms.
Measured: 1 month, 2 months, 3 months and at 3 month follow up.
Sleep quality score
Sleep quality (Pittsburg Sleep Quality Index (PSQI)) score (and subscale scores). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.17 The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: 1 month, 2 months, 3 months and at 3 month follow up.
Profile of Mood States
Profile of Mood States (POMS) score (and subscale scores). The POMS is a 40 item questionnaire assessing mood. The scale is a 5 point scale ranging from "Not at All" (0), "A Little" (1), "Moderately" (2), or "Quite a Lot" (3) or "Extremely" (4). Scores for the seven subscales are calculated by summing the numerical ratings for items that contribute to each subscale. Two of the items on the Esteem-related Affect (ERA) subscale are reverse-scored prior to being combined with the other items. They are all added or subtracted based on the subscale (TMD = [TEN+DEP+ANG+FAT+CON] - [VIG+ERA]. ) to obtain total mood disturbance. A higher score would indicate a negative outcome.
Measured: 1 month, 2 months, 3 months and at 3 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start8 Feb 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethos Research & Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Joshua Gunn, Ethos Research & Development
- Investigators
- Joshua Gunn, PhD, Principal investigator, Ethos Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247813
- Sponsor's protocol ID
- 23-02-637-1557
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
- ClinicalTrials.gov ID
- NCT06247813
- Acronym / sponsor ID
- 23-02-637-1557
- Conditions
- Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ethos Research & DevelopmentIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nerve Health | Experimental | Dietary Supplement: Nerve Health Formula |
| Oxidative Stress | Experimental | Dietary Supplement: Redox Support Formula |
| Inflammation | Experimental | Dietary Supplement: Inflammation Support Formula |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammation Support FormulaTurmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg). | Dietary supplement | Inflammation |
| Nerve Health FormulaHydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg). | Dietary supplement | Nerve Health |
| Redox Support FormulaN-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). | Dietary supplement | Oxidative Stress |
Primary outcome
Quantitative urine biomarker levels.
Time frame: 1 and 3 months of supplementation.
Quantitative urine biomarker levels after 1 and 3 months of supplementation.
Quality-of-life measures.
Time frame: 1 month of supplementation, 3 months and at 3 month follow up.
Summary scores of quality-of-life measures, patient reported outcome measurement information system 29 (PROMIS-29); assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. For overall scoring of the test (i.e., adding each response) a higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function), meaning a worse outcome.
Quality-of-life measures.
Time frame: 1 month of supplementation, 3 months and at 3 month follow up.
Summary scores of quality-of-life measures, Short Form- 36 (SF-36); The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Coding of each item varies across the measure however all items are scored so that a high score defines a more favorable health state.
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Gunn, PhD principal investigator
Ethos Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inflammation Support Formula, Nerve Health Formula and Redox Support Formula in people with Chronic Pain, run by Ethos Research & Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brianna Krause, MS ((513) 400-3057, brianna.krause@ethosrd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative urine biomarker levels. (time frame: 1 and 3 months of supplementation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.