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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
30
2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal
2 capsules, twice a day for a total of 4 capsules daily, preferably with a meal
Model Research Center, LLC
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
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.
Time frame: Day 42
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.
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.
To determine if the participant's QoL is impacted by the use of test product (TP).
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.
To determine if the use of BioPlete nutritional supplement has any impact on self-reported pain compared to placebo over the study duration.
Time frame: Day 21 and 42
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