hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

Inflammation Clinical Trial

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

Status Completed

Clinical Trial 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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Inflammation

• NCT number: NCT04600765
• Study type: Interventional
• Source: Center for Research on Environmental Chemicals in Humans
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Completion date: December 10, 2019