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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Dietary supplement: BioPlete™ Advanced Formula; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participant who is 30-65 years of age (inclusive).
2. Participant has been diagnosed with chronic pain (verbal confirmation from participant, physician records not needed) for more than 2 years at screening.
3. 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.
4. 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.
5. Participant has a body mass index (BMI) range of 18.0 - 40.0 kg/m2 (inclusive).
6. 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.
7. 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.

Exclusion Criteria:

1. Participant has uncontrolled hypotension (defined as <90 mmHg systolic and/or <60 mmHg diastolic).
2. Participant has a medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), or hepatic impairment.
3. 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).
4. 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.
5. 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.
6. 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.
7. History of hospitalization or in-patient treatment for depression or any related condition within the past five years prior to screening.
8. Is currently pregnant, lactating, or becomes pregnant during the conduct of study.
9. 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.
10. Participant has a known sensitivity or allergy to any of the ingredients in the study products.
11. 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.
12. Participant has a history of drug or alcohol abuse in the past 12 months prior to screening.
13. Participant has received or used a study product in another research study within 28 days prior to baseline/Visit 2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioPlete™ Advanced Formula; BioPlete™ Advanced Formula in Capsule Intervention: Dietary Supplement: Multi-Vitamin	Dietary supplement: BioPlete™ Advanced Formula; 2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal
Placebo Comparator: Placebo; Rice Flour in a capsule Intervention: Other: Placebo	Dietary supplement: Placebo; 2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Day 21 and 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (Day 0) in Morphine Milligrams Equivalent (MME), assessed on Days 21 and 42.	To determine if the study product has any impact on pain medication usage over the study duration (participant self-titrated up/down, or physician lowered/raised prescribed amount or dose of product).	Day 21 and 42
Within the confines of this study design, duration and population, to determine change from baseline (Day 0) the relative safety of the Test Product over 1.5 months of use.	Assessment of vital signs (i.e., changes in systolic and diastolic blood pressure and heart rate) over the study period	Day 21 and Day 42
Within the confines of this study design, duration and population, to determine change from baseline (Day 0) the relative safety of the Test Product over 1.5 months of use.	The number, type, and severity, of adverse events over the study period.	Day 21 and Day 42
Within the confines of this study design, duration and population, to determine change from baseline (Day 0) the relative safety of the Test Product over 1.5 months of use.	Comprehensive Metabolic Panel (CMP)	Day 42
Within the confines of this study design, duration and population, to determine change from baseline (Day 0) the relative safety of the Test Product over 1.5 months of use.	Complete Blood Count (CBC) with differential and platelets blood test	Day 42

Collaborators and Investigators

• Sponsor: Ethos Research & Development
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Study Director: Anthony Bier, MD, Nutrasource Pharmaceutical and Nutraceutical Services

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: E01-21-01-T0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No