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临床试验/NCT04600765
NCT04600765已完成不适用

Clinical Blood Profile Assays as Biomarkers to Directly Assess Potential Health Effects Resulting From the Controlled Elimination of Suspected Dietary and Environmental Chemical Toxins

Center for Research on Environmental Chemicals in Humans2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
2
主要终点
hsCRP Serum concentration vs serum Bisphenol A concentration

研究概览

简要总结

Dietary intervention studies thus far have failed to be replicable or causal.This is particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP)

详细描述

Dietary intervention studies thus far have failed to be replicable or causal. The results, therefore, have failed to provide clinicians and the general public with consistent and useful information on which to base reliable food-related health decisions. This is particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now that the federal CLARITY-BPA program has failed to achieve scientific consensus. Investigators propose a novel human dietary protocol that is both replicable and causal, based upon BPA's demonstrated inflammatory effects in humans. This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP), a proven clinical indicator of inflammation. Investigators used the equivalent of a USDA-defined "typical diet" followed by a PDC-reduced diet to compare blood levels of hsCRP. This proof-of-concept investigation is the first to use an easily accessible, medically-accepted clinical laboratory test to directly measure human health effects of PDC reduction. Unexpected new complications discovered during the investigation indicate that these results may yet be inconclusive for direct causal relationship. However, the novel lessons and techniques developed as a result of those discoveries offer further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal results.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Overall good health
  • hsCRP below 10
  • Standard health review blood panel normal
  • BMI less than 25
  • % body fat less than 23%
  • Resident of North San Francisco Bay area
  • Willing to eat 100% of all foods and beverages provided.
  • No food allergies
  • Not taking prescription medications or supplements including daily aspirin.
  • Written unformed consent
  • Any one not compliant with inclusion criteria.

排除标准

  • Subject in poor health
  • hsCRP above 10
  • Standard health review blood panel beyond minimum or maximum limits for any measurement.
  • Taking taking prescription medications or supplements including daily aspirin.
  • Any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, Type 2 Diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.

结局指标

主要结局

hsCRP Serum concentration vs serum Bisphenol A concentration

时间窗: 6 days

Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

次要结局

未报告次要终点

研究者

发起方
Center for Research on Environmental Chemicals in Humans
申办方类型
Other
责任方
Principal Investigator
主要研究者

William Lewis Perdue III

Chairman

Center for Research on Environmental Chemicals in Humans

研究点 (2)

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