hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

NCT04600765 | Completed

• 1 other identifier: UCSF-IRB-IRB-15-17703
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• hsCRP Serum concentration vs serum Bisphenol A concentration

  Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

  6 days

Study Arms (2)

Diet Before

ACTIVE COMPARATOR

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

Diet After

ACTIVE COMPARATOR

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

Interventions

hsCRP serum measurement of inflammation DIAGNOSTIC_TEST

hsCRP inflammation change as result of non-contaminated diet

Diet After; Diet Before

Eligibility Criteria

• Age: 60 Years - 70 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Research on Environmental Chemicals in Humans: lead

Study Sites (1)

Center for Research on Environmental Chemicals in Humans

Sonoma, California, 95476, United States

Location

Related 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.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• WILLIAM L PERDUE

  Center for Research on Environmental Chemicals in Humans

  PRINCIPAL INVESTIGATOR

• Victor I Reus, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: November 25, 2019
• Primary Completion: December 6, 2019
• Study Completion: December 10, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)