Center for Research on Environmental Chemicals in Humans
Sonoma, California, 95476, United States
NCT Number: NCT04600765
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)
Looking for future studies?
Notify Me60 year–70 year
Male
Interventional
Not applicable
Sonoma, California, 95476, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hsCRP inflammation change as result of non-contaminated diet
Time frame: 6 days
Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure
Center for Research on Environmental Chemicals in Humans
Other
Clinical Blood Profile Assays as Biomarkers to Directly Assess Potential Health Effects Resulting From the Controlled Elimination of Suspected Dietary and Environmental Chemical Toxins
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01778569
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT06993740
Anesthesia, Cardiovascular Diseases
Jakarta, DKI Jakarta, Indonesia
View Trial DetailsNCT05021835
Cardiovascular Risk, Chronic Disease
Birmingham, Alabama, United States
View Trial Details