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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Study Administrator
- 电话号码:(240) 232-2103
- 邮箱:info@ovationlab.com
学习地点
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Virginia
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Richmond、Virginia、美国、23220
- OvationLab
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接触:
- Study Administration
- 电话号码:(240) 232-2103
- 邮箱:info@ovationlab.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:CellCore - Foundational Protocol
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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.
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实验性的:CellCore - BioToxin Binder + Drainage Activator
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mosaic Envirotox Burden + Heavy Metals Urinary Panel
大体时间:Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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Assessment of environmental toxins.
Classified as low, medium, and high burden.
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Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PROMIS - Global Health
大体时间:Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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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.
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Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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PROMIS - Fatigue Short Form 4a
大体时间:Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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Validated questionnaire assessing the experience and functional impact of fatigue.
T scores range from 33.7 to 75.8.
Higher scores indicate greater fatigue.
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Measured at baseline, one month, and end of protocol (4 months for Foundational Protocol & 3 months for BioToxin Binder + Drainage Activator protocol)
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- MF-002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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