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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Before | Active Comparator | Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA. |
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| Diet After | Active Comparator | Bisphenol A reduced. Patient assigned to this arm will consume a diet analogous to atypical American diet as defined by USDA, but with known Bisphenol A sources reduced or eliminated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hsCRP serum measurement of inflammation | Diagnostic Test | hsCRP inflammation change as result of non-contaminated diet |
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| Measure | Description | Time Frame |
|---|---|---|
| hsCRP Serum concentration vs serum Bisphenol A concentration | Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure | 6 days |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
male
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| Name | Affiliation | Role |
|---|---|---|
| WILLIAM L PERDUE | Center for Research on Environmental Chemicals in Humans | Principal Investigator |
| Victor I Reus, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research on Environmental Chemicals in Humans | Sonoma | California | 95476 | United States |
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| Label | URL |
|---|---|
| Site for posting study-related information, preliminary findings, and supplemental information. | View source |
| Site for the Center for Research on Environmental Chemicals in Humans -- the 501(c)(3) non-profit supporting this study. | View source |
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Because this is an n-of-1, proof of concept study, all data will be share upon request
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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