The Committee on Human Research (CHR) at the University of San Francisco Medical School has approved the Stealth Syndromes experimental protocol.
This study approves Stealth Syndromes co-founder Lewis Perdue’s protocol to determine if standard clinical blood tests can be used to detect physiological changes that may be caused by the absorption of environmental chemicals, including endocrine disrupting compounds.
The CHR gave its go-ahead for the study on on Nov. 11, 2015.
The study is titled: “Clinical blood profile assays as biomarkers to assess potential health effects resulting from the controlled elimination of suspected dietary and environmental chemical toxins.”
The Stealth Syndromes Project is very fortunate (and grateful) to have had the guidance and institutional mentorship of UCSF Professor Victor Reus, M.D.
Dr. Reus is an internationally reknowned, and widely published biomedical scientist whose interests include neurobiology and behavior as well as the genetic origins of psychiatric disorders.
In the coming days, I will be writing numerous posts that describe the various facets of the study and examine them in more detail. Those will look at the value of a first “proof of concept study,” and what makes this study different from the hundreds of others dealing with environmental chemicals.
iRIS – Let a Thousand Computer Forms Blossom
Study submissions at UCSF are entirely electronic. Everything is submitted through the secure, web-based iRIS system which provides scores of forms in a relatively intuitive framework.
iRIS centralizes all aspects of study, makes sure that all the relevant parts of a study are included, assures compliance with human research protections, and makes all that available to the university compliance process without needing paper versions.
The complexity of the iRIS system lies somewhere between IRS income tax forms and the paperwork associated with buying and mortgaging a new house.
The following is from the iRIS FAQs:
iRIS is a web-based system that enables online application submission, real-time submission tracking, review, post-approval compliance activities, and data management. The system also functions as a document repository, providing investigators with easy access to submission records and study documents.
The committees that will conduct their reviews using the iRIS system include the:
- Committee on Human Research (CHR),
- the CTSI Clinical Research Services (CRS) Advisory Committees, and
- the Human Gamete, Embryo, and Stem Cell Research Committee (GESCR committee).
Investigators can use the system anywhere they have Internet access, helping to connect faculty, researchers, students and partners around the world. The iRIS system also has expedited the CHR review and approval process. In addition, prior to the implmenetation of iRIS, the CHR received about 5 million pieces of paper each year. The electronic system has helped us eliminate this waste and supports UCSF’s efforts to incorporate environmentally-friendly practices across campus.
Summarizing the study submission
The text below is taken directly from the UCSF iRIS system.
I have included ALL of the sections relevant to the study and omitted only those sections associated with administrative details and the online human research protection training courses I needed to pass in order to qualify as a study co-principal investigator. Correct section numbers from iRIS are used to designate each portion.
Clinical blood profile assays as biomarkers to assess potential health effects resulting from the controlled elimination of suspected dietary and environmental chemical toxins.
10.0 STUDY DESIGN
The controlled and stepwise elimination of environmental chemicals known as Chemicals of Emerging Concern (CECs) from the test subject environment will result in measurable changes in serum and urine concentrations of specific chemicals and standard clinical health biomarkers attributable to each class of CEC-containing product.
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11.2 LIST THE SPECIFIC AIMS:
- Migration/leaching of chemicals from packaging materials,
- Deliberate addition of chemicals used as preservatives, flavorings, scents, texture enhancers, coloring agents etc.4,
- Contamination by unknown compounds formed by chemical reactions among multiple intentionally used constituent chemicals18.
- Incidental contamination via migration/leaching of chemicals from harvesting and processing17.
- Home food-handling can also accelerate migration through heating, microwaving, ultraviolet light exposure (including fluorescent lighting) and the contact of oils and alcohols with plastics.
12.2 PRELIMINARY STUDIES
- time-limited (3 -16 days),
- involved relatively small numbers of test subjects (20 – 40),,
- imposed very general dietary restrictions (whole diet, fresh foods)
- Weekly blood profile as direct clinical health-linked proxies for CEC body burden.
- Weekly blood profile and urine measurements of Bisphenol A and phthlates for correlation with blood biomarkers.
- Monthly double-stranded DNA break levels.
- Monthly epigenetic profiles of specific methylation locations known to be associated with cancer, obesity, aging, infertility, or Alzheimer’s disease.
- Consumption – migration and leaching from packaging8,
- Consumption – migration and leaching from preparation stressors: heat, microwaving, ultraviolet/sunlight exposure, use of suspected utensils, preparation and eating surfaces
- Skin contact, inhalation
- Consumption – inherent content as purchased – resulting from harvest and processing
- Eliminating all products packaged in cans and plastic.
- Use of fresh products when possible.
- Products packed in glass may be substituted.
- Plastic-wrapped dry foods (bread, pasta etc)
- Plastic-wrapped wet fresh foods (veggies, cheese, meat)
- Plastic storage bags
- Milk, Cheese, dairy products
- Cutting boards
- Foods with metalized plastic “crisping” surfaces (Hot Pockets, frozen pizza)
- Paper or plastic plates, glasses and cups
- Take-out and deli plastic containers of all sorts.
- Restaurant and fast food
- Frozen and similar convenience foods
- Filtered tap water versus unfiltered.
- Homes/Offices where the water supply comes via PVC or Pex plastics.
- Beverages in pouches, boxes and “paper bottles’
- Water in hydration bladders like Camelbak
- Drip coffee maker and Keurig (plastic) as well as the Sodastream
- Laundry detergents (phthalates, fragrances, surfactants)
- Dish and dishwasher soaps (same as laundry)
- Toothpaste (plastic tube) … alternative?
- Toothbrush … what are the bristles made of?
- Fitbits, plastic watch bands
- Gore-Tex and other waterproof coatings
- Paper currency
- Wine in plastic pouches/bottles/boxes
- Distilled spirits in glass versus plastic bottles.
- Wine and beer “on tap”
15.2 INTERVIEWS, QUESTIONNAIRES, AND/OR SURVEYS WILL BE ADMINISTERED OR FOCUS GROUPS WILL BE CONDUCTED:
16.4 BENEFITS TO SOCIETY
- First connection established between dietary intervention and health indicators.
- Establishment of a framework to move risk assessment of low-level Chemicals of Emerging Concern beyond traditional toxicological ervaluations and toward molecular and epigenetic evaluations.
- Development of techniques to reduce exposure to CECs
- Emphasis on techniques (#2, above) that can easily and economically be implemented by the average person without significant disruption to daily lives.
- Overall improvement in public health and a potential path to reducing the rising incidence of obesity, Type 2 Diabetes, Alzheimer’s disease and other behavioral disorders, fertility and developmental disorders