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NCT Number: NCT07753798

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OvationLab

Richmond, Virginia, 23220, United States

Location contact

Study Administration

CONTACT

[email protected]

‪(240) 232-2103‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Lives in the United States
  • Ability to speak and read English
  • Willing and able to follow the assigned CellCore protocols and complete all required testing and questionnaires
  • Willing and able to provide informed consent

Exclusion criteria

  • 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
  • Major comorbid medical condition requiring complex specialty management that, in the practitioners' clinical judgment, would interfere with safe study participation
  • Anticipated initiation of additional detoxification products, major dietary changes, or other significant co-interventions during the study period
  • Unable or unwilling to provide informed consent

Treatment and study plan

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.

Primary outcomes

  1. Mosaic Envirotox Burden + Heavy Metals Urinary Panel

    Time frame: 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 outcomes

  1. PROMIS - Global 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)

    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.

  2. PROMIS - Fatigue Short Form 4a

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Administrator

CONTACT

[email protected]

‪(240) 232-2103‬

Sponsors and collaborators

Lead sponsor

OvationLab

Network

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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