Stricter protocols combined with a clinical serum biomarker can increase replicability and causality for dietary intervention studies. Plus empirical data on BPA regrettable substitutions

ABSTRACT Effective regulation of harmful environmental chemicals found in wide variety of consumer products and consumables has been thwarted by the lack of agreement between government scientists and university/academic laboratories regarding the quantification of significant human harms. This is particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now that the federal CLARITY-BPA program has failed to achieve any credible, human-significant scientific consensus. Because of this disagreement, direct, clinical human experimental data is vital to resolving this situation. In an effort to develop direct human-relevant data, some academic investigators have employed dietary intervention studies in an attempt to shed light on the controversy. Unfortunately, dietary intervention efforts thus far have not demonstrated causality or replicability. Investigators of this study propose a novel human dietary intervention protocol that can be both replicable and causal. 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 phenomena discovered during the investigation offer study protocol modifications to enhance widespread replicability, and economically practical expansion to a substantial proportion of the approximately 84,000 mostly unregulated chemicals found in the human environment. In addition, our LC/MS-MS results offer the first direct quantitative human clinical evidence (of which we are aware) confirming the existence of regrettable substitutions in which product manufacturers have reduced BPA usage while substituting Bisphenol analogues that appear to equal or exceed BPA human toxicity. Bolstered by the unexpected results in this proof-of-concept investigation, novel lessons and techniques described herein may further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal human results.