Environmental Toxins, General Health
Conditions
Brief summary
The primary purpose of this study is to evaluate the effects of CellCore protocols on environmental toxicant biomarkers among adult patients with high baseline toxicant levels. Patients will be allocated to one of two CellCore protocols (Foundational Protocol or BioToxin Binder/Drainage Activator) based on overall physical health, mental health, and fatigue levels at baseline. A prospective, practitioner-led, open-label, single-arm intervention with the CellCore protocols will be conducted to measure pre- and post-intervention changes in urinary environmental toxicant biomarkers and validated, patient-reported health outcomes.
Interventions
DIETARY_SUPPLEMENTCellCore Foundational Protocol
The CellCore Foundational Protocol is a four-phase, four-month supplement program designed to support drainage, gut and immune balance, whole-body immune support, and systemic detoxification in a stepwise sequence.
DIETARY_SUPPLEMENTCellCore - BioToxin Binder & Drainage Activator
BioToxin Binder is a first-step detox support supplement that uses CellCore BioActive Carbon® carbon technology to bind biotoxins while supporting gut microbiome balance, immunity, digestive function, cellular repair, and energy production. Drainage Activator is a drainage-support supplement aimed at the extracellular matrix and lymphatic drainage, using herbs and mushrooms to help open drainage pathways and support the body's natural detox processes. This is a three-month combination protocol.
Sponsors
OvationLab
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants will be allocated to one of two CellCore protocols based upon their overall physical health at baseline. There will be no control condition or comparator. The comparisons are within-individuals and not between-groups.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult between 25 and 65 years of age 2. Documented elevated urinary environmental toxicant levels above the 75th percentile of at least 5 toxins on baseline environmental toxin test 3. PROMIS - Global Health - Physical Health t-scores \< 42.4 for Foundational Protocol (otherwise BioToxin Binder/Drainage Activator Protocol) 4. Currently receiving care from a qualified, participating practitioner 5. Lives in the United States 6. Ability to speak and read English 7. Willing and able to follow the assigned CellCore protocols and complete all required testing and questionnaires 8. Willing and able to provide informed consent
Exclusion criteria
1. Currently undergoing active chelation therapy 2. Participation in a structured detoxification program within the prior 60 days, including use of activated charcoal, bentonite/zeolite clay, chlorella, cholestyramine 3. Ongoing occupational toxic exposure (e.g., working on golf course, dry cleaning facility) that cannot be reduced or controlled during the study period 4. Pregnancy or lactation, or planning pregnancy during the study period 5. Major comorbid medical condition requiring complex specialty management that, in the practitioners' clinical judgment, would interfere with safe study participation 6. Anticipated initiation of additional detoxification products, major dietary changes, or other significant co-interventions during the study period 7. Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mosaic Envirotox Burden + Heavy Metals Urinary Panel | Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol) | Assessment of environmental toxins. Classified as low, medium, and high burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Global Health | Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol) | Validated questionnaire assessing global physical and mental health. T scores range from 16.2 to 67.7 for physical health and from 21.2 to 67.6 for mental health. Higher scores indicate better physical and mental health. |
| PROMIS - Fatigue Short Form 4a | Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol) | Validated questionnaire assessing the experience and functional impact of fatigue. T scores range from 33.7 to 75.8. Higher scores indicate greater fatigue. |
Countries
United States
Contacts
CONTACTStudy Administrator
Outcome results
None listed