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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600765
• Other study ID #: UCSF-IRB-IRB-15-17703
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: January 2021
• Source: Center for Research on Environmental Chemicals in Humans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 10, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

Diagnostic Test:
• hsCRP serum measurement of inflammation
hsCRP inflammation change as result of non-contaminated diet

Locations

Country	Name	City	State
United States	Center for Research on Environmental Chemicals in Humans	Sonoma	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Research on Environmental Chemicals in Humans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP Serum concentration vs serum Bisphenol A concentration	Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure	6 days

External Links

•   Site for posting study-related information, preliminary findings, and supplemental information.
•   Site for the Center for Research on Environmental Chemicals in Humans -- the 501(c)(3) non-profit supporting this study.