hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Diagnostic Test: hsCRP serum measurement of inflammation

• Registration Number: NCT04600765
• Lead Sponsor: Center for Research on Environmental Chemicals in Humans

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2019-11-25
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-10
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet Before	hsCRP serum measurement of inflammation	Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA.
Diet After	hsCRP serum measurement of inflammation	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.

Primary Outcome Measures

Name	Time	Method
hsCRP Serum concentration vs serum Bisphenol A concentration	6 days	Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

Trial Locations

Locations (1)

Center for Research on Environmental Chemicals in Humans; 🇺🇸 Sonoma, California, United States