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

NCT05278533 | Completed

• 1 other identifier: E01-21-01-T0010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline (Day 0) in Foundation Pain Index (FPI) (0-100; higher is worse), assessed on Days 21 and 42.

  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.

  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.

  Day 21 and 42

Other Outcomes (5)

• Change from baseline (Day 0) in Morphine Milligrams Equivalent (MME), assessed on Days 21 and 42.

  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.

  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.

  Day 21 and Day 42

Study Arms (2)

BioPlete™ Advanced Formula

EXPERIMENTAL

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

Dietary Supplement: BioPlete™ Advanced Formula

Placebo

PLACEBO COMPARATOR

Rice Flour in a capsule Intervention: Other: Placebo

Dietary Supplement: Placebo

Interventions

BioPlete™ Advanced Formula DIETARY_SUPPLEMENT

2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal

BioPlete™ Advanced Formula

Placebo DIETARY_SUPPLEMENT

2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethos Research & Development: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (2)

Model Research Center, LLC

Tampa, Florida, 33615, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Bier, MD

  Nutrasource Pharmaceutical and Nutraceutical Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: November 2, 2021
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)