Revised Protocol: UCSF IRB/CHR Number: 15-17703: Approved by IRB/CHR, November 14, 2018
W. Lewis Perdue, Dr. Victor I. Reus MD
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.
This study is the first of its kind to go beyond simply measuring serum and urine concentrations of the subject chemicals. Instead, this study will measure clinically useful outcomes using widely accepted diagnostic tests available at most medical facilities.
The investigators of this study recommend a revised protocol to increase reproducibility and decrease costs.
This revision is based on 2-1/2 years of intensive research that has determined that the original protocol would be impractical, too expensive for allocated resources, and could not be replicated by other investigators.
These revisions did not result from a single incident of sudden enlightenment. Instead, they are the result of a steady accumulation of insight built upon the closer scrutiny of previously published diet intervention studies. Underpinning that was the accumulated discovery of confounding basic science factors never before considered in these previous studies. which rendered them irreproducible.
Chief among the non-replicability of is the fact that the food supply chain is ubiquitously contaminated with widely varying and uncontrolled levels of Bisphenol A, phthalates and other environmental chemicals.
The investigators believe they have developed a reliable method of preparing and sourcing foods that will allow consistent results across other investigations.
NOTE: This revised protocol is followed by four appendices containing supplemental material excerpted from our internal reproducibility problem-solving working paper that offers greater perspective on the rationale and feasibility of the revised protocol.