Chronic PainNCT05278533

Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ in Adults With Chronic Pain

A study testing BioPlete™ Advanced Formula in people with Chronic Pain, run by Ethos Research & Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: BioPlete™ Advanced Formula
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: 2 Nov 2021to 5 Oct 2022
Phase: Interventional
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 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant who is 30-65 years of age (inclusive).
Participant has been diagnosed with chronic pain (verbal confirmation from participant, physician records not needed) for more than 2 years at screening.
Participant with long term (more than 3 months) and current use of prescribed opioid medication for pain management, with a stable dosage at least 3 months prior to screening.
Participant scores a 7 or higher at the screening visit on an 11-point NRS for "average pain or discomfort over the past month", or participant scores 40 or higher on the MME Scale at the screening visit, or both.
Participant has a body mass index (BMI) range of 18.0 - 40.0 kg/m2 (inclusive).
Female participants of childbearing potential (i.e., participants who are not surgically sterilized or not post-menopausal [defined as amenorrhea for greater than 1 year], or transgendered males with retained ovaries and uterus) must agree to use a medically approved method of birth control or abstain from heterosexual intercourse throughout the duration of the study and have a negative urine pregnancy result at screening. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner must be used, or abstinence from heterosexual intercourse.
Participant is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Who cannot join

Participant has uncontrolled hypotension (defined as <90 mmHg systolic and/or <60 mmHg diastolic).
Participant has a medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), or hepatic impairment.
Participant has a medical history of previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to the screening visit, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
Participant has a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Participant is currently taking any dietary supplement that contains active ingredients known to modulate FPI scoring i.e., any active ingredients in the Test Product.
Participant received a vaccine for Coronavirus Disease 2019 (COVID-19) or any other vaccination in the last 2 weeks prior to randomization or is planning to receive a vaccination during the study period.

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History of hospitalization or in-patient treatment for depression or any related condition within the past five years prior to screening.
Is currently pregnant, lactating, or becomes pregnant during the conduct of study.
Participant has a history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the study results or the potential participant's ability to participate in the study.
Participant has a known sensitivity or allergy to any of the ingredients in the study products.
Participant has any dietary restriction (e.g., vegans or vegetarians that do not consume gelatin) that prevents the participant from consuming any of the ingredients in the study products.
Participant has a history of drug or alcohol abuse in the past 12 months prior to screening.
Participant has received or used a study product in another research study within 28 days prior to baseline/Visit 2.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Model Research Center, LLC
Tampa, Florida, 33615
Palm Beach Research Center
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Early-stage Study to Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on Quality of Life in Adults With Chronic Pain

This study is a randomized, double-blind, placebo controllled parallel design study to evaluate the use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on quality of life in adults with chronic pain. Eligible participants that provide informed consent and pass the screening visit procedures will be randomized in a 4:1 ratio to active product or placebo at the baseline visit (V2) and will return after 3 and 6 weeks of supplementation for study assessments.

Read the detailed description

A newly developed biomarker test panel, named the Foundation Pain Index (FPI), has been demonstrated to have applications in the potential medical care of individuals living with chronic pain. The research to date has demonstrated a nutritional link to pain amongst other potential causes or collaterals related to pain. The current research points to nutritional deficiencies, metabolic abnormalities and oxidative stressors as all being related to pain and potential pain management. Preliminary research has found that the novel biomarker testing platform allows for the treating physician to utilize non-opioid means for helping to manage quality of life and pain medication usage (opioid and non-opioid). Using the FPI, a systems biology approach will be taken to identify potential biomarkers related to pain and pain management.

The present study is designed to determine if individuals with chronic pain can benefit from the FPI and the nutritional supplement BioPlete™

A total of 30 participants will be randomized in a 4:1 ratio for the study, with 24 participants in the Test Product arm and 6 participants in the placebo arm. The study duration for this trial can last up to a total of approximately 2.5 months (73 days) in duration.

Conditions: Chronic Pain
Being tested: BioPlete™ Advanced Formula, Placebo
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioPlete™ Advanced FormulaDietary supplement
2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal
PlaceboDietary supplement
2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal

Study groups in NCT05278533
Study group	Role	What they receive
BioPlete™ Advanced Formula	Experimental	BioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin Receives: Dietary Supplement: BioPlete™ Advanced Formula
Placebo	Placebo comparator	Rice Flour in a capsule Intervention: Other: Placebo Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 42.
To determine if the participant's quality of life (QoL) is impacted by the use of BioPlete nutritional supplement over the study duration.
Measured: Day 42

Secondary outcomes (3)

Change from baseline (Day 0) in Foundation Pain Index (FPI) (0-100; higher is worse), assessed on Days 21 and 42.
To determine if the use of BioPlete nutritional supplement can impact individual levels or aspects of each part of the FPI score compared to placebo over the study duration.
Measured: Day 21 and Day 42
Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 21.
To determine if the participant's QoL is impacted by the use of test product (TP).
Measured: Day 21
Change from baseline (Day 0) in Numeric Rating Scale (NRS) scores for pain (0-10, higher is worse), assessed on Days 21 and 42.
To determine if the use of BioPlete nutritional supplement has any impact on self-reported pain compared to placebo over the study duration.
Measured: Day 21 and 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20215 Oct 2022

First posted14 Mar 2022
Study start2 Nov 2021
Primary completion5 Oct 2022
Study completion5 Oct 2022

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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05278533
Sponsor's protocol ID: E01-21-01-T0010
Status last verified: Jun 2023
First submitted: 4 Mar 2022
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Early-stage Study to Evaluate the Use of the Foundation Pain Index and the Nutritional Supplement BioPlete™ on Quality of Life in Adults With Chronic Pain
ClinicalTrials.gov ID: NCT05278533
Acronym / sponsor ID: E01-21-01-T0010
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Ethos Research & DevelopmentIndustry (pharma, biotech, devices)
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study start: 2 Nov 2021 (actual)
Primary completion: 5 Oct 2022 (actual)
Study completion: 5 Oct 2022 (actual)
First posted: 14 Mar 2022 (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.

Detailed description

The present study is designed to determine if individuals with chronic pain can benefit from the FPI and the nutritional supplement BioPlete™

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm	Type	Receives
BioPlete™ Advanced Formula	Experimental	Dietary Supplement: BioPlete™ Advanced FormulaBioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin
Placebo	Placebo comparator	Dietary Supplement: PlaceboRice Flour in a capsule Intervention: Other: Placebo

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant who is 30-65 years of age (inclusive).
Participant has been diagnosed with chronic pain (verbal confirmation from participant, physician records not needed) for more than 2 years at screening.
Participant with long term (more than 3 months) and current use of prescribed opioid medication for pain management, with a stable dosage at least 3 months prior to screening.
Participant scores a 7 or higher at the screening visit on an 11-point NRS for "average pain or discomfort over the past month", or participant scores 40 or higher on the MME Scale at the screening visit, or both.
Participant has a body mass index (BMI) range of 18.0 - 40.0 kg/m2 (inclusive).

Key exclusion criteria (13 listed)

Participant has uncontrolled hypotension (defined as <90 mmHg systolic and/or <60 mmHg diastolic).
Participant has a medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), or hepatic impairment.
Participant has a medical history of previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to the screening visit, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
Participant has a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Participant is currently taking any dietary supplement that contains active ingredients known to modulate FPI scoring i.e., any active ingredients in the Test Product.

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
BioPlete™ Advanced Formula2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal	Dietary supplement	BioPlete™ Advanced Formula
Placebo2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal	Dietary supplement	Placebo

Primary outcome

Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 42.
Time frame: Day 42
To determine if the participant's quality of life (QoL) is impacted by the use of BioPlete nutritional supplement over the study duration.

3 secondary outcomes

Change from baseline (Day 0) in Foundation Pain Index (FPI) (0-100; higher is worse), assessed on Days 21 and 42.
Time frame: Day 21 and Day 42
Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 21.
Time frame: Day 21
Change from baseline (Day 0) in Numeric Rating Scale (NRS) scores for pain (0-10, higher is worse), assessed on Days 21 and 42.
Time frame: Day 21 and 42

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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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.

Anthony Bier, MD study director

Nutrasource Pharmaceutical and Nutraceutical Services

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BioPlete™ Advanced Formula in people with Chronic Pain, run by Ethos Research & Development at 2 sites 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline (Day 0) in 36-Item Short Form Survey (SF-36) questionnaire scores (0-100; higher is better), assessed on Day 42. (time frame: Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278533.

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 22 Jun 2023.