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OpenTrials
Completed

NCT Number: NCT04600765

hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

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)

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Key information

Age range

60 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Research on Environmental Chemicals in Humans

Sonoma, California, 95476, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hsCRP serum measurement of inflammation

Diagnostic Test

hsCRP inflammation change as result of non-contaminated diet

Primary outcomes

  1. hsCRP Serum concentration vs serum Bisphenol A concentration

    Time frame: 6 days

    Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure

Sponsors and collaborators

Lead sponsor

Center for Research on Environmental Chemicals in Humans

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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