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hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

Sponsor
Center for Research on Environmental Chemicals in Humans (Other)
Overall Status
Completed
CT.gov ID
NCT04600765
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
15
Actual Duration (Days)
2
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: hsCRP serum measurement of inflammation
 N/A

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

Study Type:
Interventional
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 :
Nov 25, 2019
Actual Primary Completion Date :
Dec 6, 2019
Actual Study Completion Date :
Dec 10, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. hsCRP Serum concentration vs serum Bisphenol A concentration [6 days]

    Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
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:
Oct 23, 2020
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Inflammation

Study Results

No Results Posted as of Jan 27, 2021