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hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04600765
Recruitment Status : Completed
First Posted : October 23, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
William Lewis Perdue III, Center for Research on Environmental Chemicals in Humans

Study Description
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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)

Condition or disease Intervention/treatment Phase
Inflammation Diagnostic Test: hsCRP serum measurement of inflammation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 25, 2019
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 10, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. hsCRP Serum concentration vs serum Bisphenol A concentration [ Time Frame: 6 days ]
    Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600765


Locations
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United States, California
Center for Research on Environmental Chemicals in Humans
Sonoma, California, United States, 95476
Sponsors and Collaborators
Center for Research on Environmental Chemicals in Humans
Investigators
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Principal Investigator: WILLIAM L PERDUE Center for Research on Environmental Chemicals in Humans
Principal Investigator: Victor I Reus, MD University of California, San Francisco
More Information
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Additional Information:

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Responsible Party: William Lewis Perdue III, Chairman, Center for Research on Environmental Chemicals in Humans
ClinicalTrials.gov Identifier: NCT04600765    
Other Study ID Numbers: UCSF-IRB-IRB-15-17703
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Because this is an n-of-1, proof of concept study, all data will be share upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes