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hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600765
Enrollment
1
Registered
2020-10-23
Start date
2019-11-25
Completion date
2019-12-10
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

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.

Interventions

DIAGNOSTIC_TESThsCRP serum measurement of inflammation

hsCRP inflammation change as result of non-contaminated diet

Sponsors

Center for Research on Environmental Chemicals in Humans
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
60 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Overall good health * hsCRP below 10 * Standard health review blood panel normal * BMI less than 25 * % body fat less than 23% * Resident of North San Francisco Bay area * Willing to eat 100% of all foods and beverages provided. * No food allergies * Not taking prescription medications or supplements including daily aspirin. * Written unformed consent * Any one not compliant with inclusion criteria.

Exclusion criteria

* Subject in poor health * hsCRP above 10 * Standard health review blood panel beyond minimum or maximum limits for any measurement. * Taking taking prescription medications or supplements including daily aspirin. * Any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, Type 2 Diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.

Design outcomes

Primary

MeasureTime frameDescription
hsCRP Serum concentration vs serum Bisphenol A concentration6 daysWill decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026