BioPlete for Chronic Pain

No longer recruiting at 1 trial location

Overseen By Jevaneeh Rubio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ethos Research & Development

Must be taking: Opioids

Must not be taking: Dietary supplements

Disqualifiers: Heart disease, Kidney disease, Hepatic impairment, others

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new nutritional supplement, BioPlete™ Advanced Formula, can improve the quality of life for adults with chronic pain. Participants will receive either the BioPlete™ supplement or a placebo to determine any noticeable difference in pain management. It targets individuals who have experienced chronic pain for over two years and are currently using prescribed opioids for relief. Participants must maintain a stable medication dosage for at least three months before joining. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance chronic pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on a stable dosage of prescribed opioid medication for at least 3 months before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that specific safety information for BioPlete™ Advanced Formula is not yet available. However, similar dietary supplements are usually well-tolerated. Products like these, including multi-vitamins, are generally safe for most users when used as directed. Studies of similar supplements have not reported serious side effects or problems. As with any supplement, following the instructions and consulting a healthcare provider if there are concerns is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic pain, which often rely on medications like NSAIDs or opioids, BioPlete™ Advanced Formula is a nutritional supplement designed to manage pain through a unique blend of vitamins and minerals. Researchers are excited about BioPlete™ because it offers a non-pharmaceutical approach, potentially reducing the risk of side effects associated with traditional pain medications. Additionally, this formula may address nutritional deficiencies that can exacerbate pain, providing a holistic method to improve overall well-being alongside pain management.

What evidence suggests that BioPlete™ Advanced Formula might be an effective treatment for chronic pain?

Research shows that BioPlete™ Advanced Formula, which participants in this trial may receive, addresses issues like ongoing inflammation, increased cell damage, and imbalances in brain chemicals, often linked to chronic pain. These problems can worsen chronic pain, so addressing them might help reduce it. Although specific clinical data on BioPlete™'s effectiveness for chronic pain is limited, the supplement targets key factors believed to contribute to pain. The formula also includes important nutrients that might help with deficiencies affecting overall health and possibly pain perception. While direct evidence in humans remains limited, basic science suggests it could benefit those with chronic pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Anthony Bier, MD

Principal Investigator

Nutrasource Pharmaceutical and Nutraceutical Services

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either BioPlete™ Advanced Formula or placebo for 6 weeks

6 weeks

3 visits (in-person) at baseline, 3 weeks, and 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BioPlete™ Advanced Formula
• Placebo

How Is the Trial Designed?

Group I: BioPlete™ Advanced Formula Experimental Treatment 1 Intervention

BioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin

Group II: Placebo Placebo Group 1 Intervention

Rice Flour in a capsule Intervention: Other: Placebo

Who Is Running the Clinical Trial?

Ethos Research & Development

Lead Sponsor

Trials

3

Recruited

110+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Published Research Related to This Trial

In a study involving healthy subjects, cellobiose was found to be safe and well-tolerated, with a maximum tolerated dose identified as 20 g for single use and 15 g twice daily for repeated consumption.

Despite some mild gastrointestinal side effects like flatulence and transient diarrhea in sensitive individuals, the overall tolerability rating was high, indicating that cellobiose could be a beneficial low-caloric bulking agent in food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Dose-Escalation Study Demonstrates the Safety and Tolerability of Cellobiose in Healthy Subjects. Moré, MI., Postrach, E., Bothe, G., et al.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-chronic-pain-8-2021-73b14

Evaluate the Use of the Foundation Pain Index and ...

The research does not provide specific safety data for BioPlete™ Advanced Formula ... Participants are monitored for safety and effectiveness after treatment.

2.

ctv.veeva.com

ctv.veeva.com/study/evaluate-the-use-of-the-foundation-pain-index-and-the-nutritional-supplement-bioplete-in-adults-wit

Evaluate the Use of the Foundation Pain Index and the ...

This study is a randomized, double-blind, placebo controllled parallel design study to evaluate the use of the Foundation Pain Index and the ...

3.

bioplete.com

bioplete.com/products/bioplete%E2%84%A2-advanced-formula

BioPlete™ Advanced Formula

BioPlete has been designed to address the chronic inflammation, increased oxidative stress, abnormal neurotransmitter status, and micronutrient deficiencies ...

4.

bioplete.com

bioplete.com/

Bioplete.com

BioPlete products have been designed to address the chronic inflammation, increased oxidative stress, abnormal neurotransmitter status, and micronutrient ...

5.

sigma.larvol.com

sigma.larvol.com/facility.php?FacilityId=19382592

Nutrasource Clinical Trial Site

NCT06949631: Study on the Effects of Resistant Potato Starch on Gut Bacteria in Healthy Adults ... US. BioPlete™ Advanced Formula, Placebo. Ethos Research & ...

6.

prod.adv-bio.com

prod.adv-bio.com/SDS-US/6024sdsus.pdf

Safety Data Sheet

Personal precautions, protective equipment and emergency procedures Not required. · Environmental precautions: Dilute with plenty of water. · ...

7.

images.thdstatic.com

images.thdstatic.com/catalog/pdfImages/1b/1b38b8cc-6de1-40d6-9d64-deda2d332bf9.pdf

SBM LIFE SCIENCE CORP.

Do not eat, drink or smoke when using this product. Avoid breathing mist and spray. Use only outdoors or in a well-ventilated area.