Clinical trial NCT04600765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Center for Research on Environmental Chemicals in Humans
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 1
Sex: MALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: hsCRP Serum concentration vs serum Bisphenol A concentration
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sonoma
country: United States
facility: Center for Research on Environmental Chemicals in Humans
state: California
Study officials:
affiliation: Center for Research on Environmental Chemicals in Humans
name: WILLIAM L PERDUE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Victor I Reus, MD
role: PRINCIPAL_INVESTIGATOR
References: