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

NCT07753798 | Not Yet Recruiting

• 1 other identifier: MF-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Toxins; General Health

Outcome Measures

Primary Outcomes (1)

• Mosaic Envirotox Burden + Heavy Metals Urinary Panel

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

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

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

CellCore - Foundational Protocol

EXPERIMENTAL

Dietary Supplement: CellCore Foundational Protocol

CellCore - BioToxin Binder + Drainage Activator

EXPERIMENTAL

Dietary Supplement: CellCore - BioToxin Binder & Drainage Activator

Interventions

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 - Foundational Protocol

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.

CellCore - BioToxin Binder + Drainage Activator

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OvationLab: lead

Study Sites (1)

OvationLab

Richmond, Virginia, 23220, United States

Location

Central Study Contacts

Study Administrator

CONTACT

‪(240) 232-2103‬; info@ovationlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)