Prospective Human Study Evaluating Changes in Markers of Detoxification, Overall Physical and Mental Health, and Fatigue Following Supplementation With CellCore Protocols

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorOvationLab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult between 25 and 65 years of age

Documented elevated urinary environmental toxicant levels above the 75th percentile of at least 5 toxins on baseline environmental toxin test

PROMIS - Global Health - Physical Health t-scores < 42.4 for Foundational Protocol (otherwise BioToxin Binder/Drainage Activator Protocol)

Currently receiving care from a qualified, participating practitioner

Disqualifiers

Currently undergoing active chelation therapy

Participation in a structured detoxification program within the prior 60 days, including use of activated charcoal, bentonite/zeolite clay, chlorella, cholestyramine

Ongoing occupational toxic exposure (e.g., working on golf course, dry cleaning facility) that cannot be reduced or controlled during the study period

Pregnancy or lactation, or planning pregnancy during the study period

Trial design

Design model

Parallel

Treatments tested in this trial

  • CellCore Foundational Protocol

    Dietary supplement

    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.

  • CellCore - BioToxin Binder & Drainage Activator

    Dietary supplement

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CellCore - Foundational ProtocolExperimental treatment 1 intervention
Group B: CellCore - BioToxin Binder + Drainage ActivatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mosaic Envirotox Burden + Heavy Metals Urinary Panel

Assessment of environmental toxins. Classified as low, medium, and high burden.

Time frame
Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)

Secondary outcomes

1

PROMIS - Global Health

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.

Time frame
Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
2

PROMIS - Fatigue Short Form 4a

Validated questionnaire assessing the experience and functional impact of fatigue. T scores range from 33.7 to 75.8. Higher scores indicate greater fatigue.

Time frame
Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)

Other outcomes

Sponsors and contacts

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