Environmental ToxinsNCT07753798
Prospective Human Study Evaluating Changes in Markers of Detoxification, Overall Physical and Mental Health, and Fatigue Following Supplementation With CellCore Protocols
A study testing CellCore Foundational Protocol and CellCore - BioToxin Binder & Drainage Activator in people with Environmental Toxins and General Health, run by OvationLab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Environmental Toxins, General Health
- What is being tested?
- CellCore Foundational Protocol and CellCore - BioToxin Binder & Drainage Activator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OvationLab
Richmond, Virginia, 23220
Study Administration, (240) 232-2103, info@ovationlab.com
About this study
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
- Being tested
- CellCore Foundational Protocol, CellCore - BioToxin Binder & Drainage Activator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellCore Foundational ProtocolDietary 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 ActivatorDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| CellCore - Foundational Protocol | Experimental | Not described Receives: Dietary Supplement: CellCore Foundational Protocol |
| CellCore - BioToxin Binder + Drainage Activator | Experimental | Not described Receives: Dietary Supplement: CellCore - BioToxin Binder & Drainage Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mosaic Envirotox Burden + Heavy Metals Urinary Panel
Assessment of environmental toxins. Classified as low, medium, and high burden.
Measured: 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
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.
Measured: 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
Validated questionnaire assessing the experience and functional impact of fatigue. T scores range from 33.7 to 75.8. Higher scores indicate greater fatigue.
Measured: Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start28 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ToxinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OvationLab
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753798
- Sponsor's protocol ID
- MF-002
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public data repository
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Human Study Evaluating Changes in Markers of Detoxification, Overall Physical and Mental Health, and Fatigue Following Supplementation With CellCore Protocols
- ClinicalTrials.gov ID
- NCT07753798
- Acronym / sponsor ID
- MF-002
- Conditions
- Environmental Toxins, General Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OvationLabResearch network
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CellCore - Foundational Protocol | Experimental | Dietary Supplement: CellCore Foundational Protocol |
| CellCore - BioToxin Binder + Drainage Activator | Experimental | Dietary Supplement: CellCore - BioToxin Binder & Drainage Activator |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellCore Foundational ProtocolThe 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 supplement | CellCore - Foundational Protocol |
| CellCore - BioToxin Binder & Drainage ActivatorBioToxin 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. | Dietary supplement | CellCore - BioToxin Binder + Drainage Activator |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. Public data repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellCore Foundational Protocol and CellCore - BioToxin Binder & Drainage Activator in people with Environmental Toxins and General Health, run by OvationLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Administrator ((240) 232-2103, info@ovationlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.