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

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)

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Diagnostic test: hsCRP serum measurement of inflammation

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sonoma, California, United States, 95476
      • Center for Research on Environmental Chemicals in Humans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet Before; Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA.	Diagnostic test: hsCRP serum measurement of inflammation; hsCRP inflammation change as result of non-contaminated diet
Active Comparator: Diet After; Bisphenol A reduced. Patient assigned to this arm will consume a diet analogous to atypical American diet as defined by USDA, but with known Bisphenol A sources reduced or eliminated.	Diagnostic test: hsCRP serum measurement of inflammation; hsCRP inflammation change as result of non-contaminated diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hsCRP Serum concentration vs serum Bisphenol A concentration	Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure	6 days

Collaborators and Investigators

• Sponsor: Center for Research on Environmental Chemicals in Humans
• Investigators: Principal Investigator: WILLIAM L PERDUE, Center for Research on Environmental Chemicals in Humans; Principal Investigator: Victor I Reus, MD, University of California, San Francisco

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: UCSF-IRB-IRB-15-17703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Because this is an n-of-1, proof of concept study, all data will be share upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No