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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Dietary Supplement: BioPlete™ Advanced Formula
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking: Quadruple


Arms and Interventions

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

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 |