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hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hsCRP serum measurement of inflammation
Sponsored by
Center for Research on Environmental Chemicals in Humans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for Research on Environmental Chemicals in Humans

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diet Before

Diet After

Arm Description

Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA.

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.

Outcomes

Primary Outcome Measures

hsCRP Serum concentration vs serum Bisphenol A concentration
Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
January 25, 2021
Sponsor
Center for Research on Environmental Chemicals in Humans
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1. Study Identification

Unique Protocol Identification Number
NCT04600765
Brief Title
hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Research on Environmental Chemicals in Humans

4. Oversight

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
Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet Before
Arm Type
Active Comparator
Arm Description
Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA.
Arm Title
Diet After
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
hsCRP serum measurement of inflammation
Intervention Description
hsCRP inflammation change as result of non-contaminated diet
Primary Outcome Measure Information:
Title
hsCRP Serum concentration vs serum Bisphenol A concentration
Description
Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure
Time Frame
6 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WILLIAM L PERDUE
Organizational Affiliation
Center for Research on Environmental Chemicals in Humans
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor I Reus, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research on Environmental Chemicals in Humans
City
Sonoma
State/Province
California
ZIP/Postal Code
95476
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Because this is an n-of-1, proof of concept study, all data will be share upon request
Links:
URL
https://stealthsyndromestudy.com
Description
Site for posting study-related information, preliminary findings, and supplemental information.
URL
https://crechcenter.org
Description
Site for the Center for Research on Environmental Chemicals in Humans -- the 501(c)(3) non-profit supporting this study.

Learn more about this trial

hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

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