Prospective Human Study Evaluating Changes in Markers of Detoxification, Overall Physical and Mental Health, and Fatigue Following Supplementation With CellCore Protocols
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mosaic Envirotox Burden + Heavy Metals Urinary Panel
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CellCore - Foundational Protocol
干预措施: CellCore Foundational Protocol (Dietary Supplement)
CellCore - BioToxin Binder + Drainage Activator
干预措施: CellCore - BioToxin Binder & Drainage Activator (Dietary Supplement)
结局指标
主要结局
Mosaic Envirotox Burden + Heavy Metals Urinary Panel
时间窗: 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.
次要结局
- 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))