Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals (EDCs) in Women of Child-Bearing Age and Their Partners
Phase: NA
Conditions: Endocrine Disrupting Chemicals, Environmental Exposure, Health Literacy, Bisphenol A, Phthalate Exposure, Survey
Sponsor: Million Marker Wellness, Inc.

Clinical Trial Registration PRS Cover Page
Document:
Protocol
Official Title:
Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals
(EDCs) in Women of Child-Bearing Age and Their Partners
NCT Number:
NCT05780047
Document Date:
July 9, 2021

Title of Study: Renown Institute for Health Innovation-Million Marker Detect and Detox Pilot
Principle Investigator: Joseph Grzymski, PhD
Co-Investigator: Jenna Hua
Study Purpose and Narrative
1. Describe the study background, significance, and purpose/hypothesis/research
questions.
The exposome encompasses all of the environmental exposures across one’s lifespan1
and includes toxic chemical exposures from food, water, air, and household and
consumer products.2 It is the exposome and the genome that determines our health.1
And in fact, environmental factors are responsible for more than 70% of the risk of
developing chronic diseases.3 Thus, assessing the state of the exposome of the
population is a crucial factor in assessing public health and advancing
recommendations and regulations.
There are over 85,000 man-made chemicals in use today in the U.S., but only 1% have
sufficient safety information.4 Individuals come into contact with these chemicals every
day through food and products, such as personal care and household products. Many of
these products contain endocrine disrupting chemicals (EDCs). Due to their
ubiquitousness, impacts on the environment, wildlife, and human health, EDCs have
become a major public health concern.5 Data from the NHANES has shown that more
than 90% of US adults have detectable levels of common EDCs, such as bisphenol A
(BPA) and phthalates, in their urine.6,7 EDC exposures are particularly concerning for
reproductive-aged women. Women are the primary consumers of many personal care
products,7 and exposures during pregnancy predispose the fetus to adverse health
effects later in life.4
Exposure to EDCs across the U.S. population is suspected to cause many chronic
diseases and disorders, including IQ loss, intellectual disability, attention-deficit
hyperactivity disorder, childhood obesity, adult obesity, Type 2 diabetes, cardiovascular
and metabolic disease, genital defects, infertility, and mortality from reduced
testosterone.5,8–10 The economic burden of the diseases caused by all EDC exposure is
estimated at $340 billion in the United States, which is 2.33% of the GDP.15 In order to
mitigate the health impacts and corresponding financial burden of exposures to EDCs,
large-scale biomonitoring of populations is crucial for developing Health
recommendations and regulations. Further, individuals must have access to an
affordable, easy, and rapid way to test their exposures to a wide range of EDCs so that
they can reduce their exposures.
Million Marker (MM) is a recent company that offers the first at-home EDC testing kit
and environmental exposure journal app. We provide affordable and scalable
personalized environmental exposure testing and analysis followed by a tailored
intervention program to empower individuals to optimize their health, prevent diseases,
and manage existing conditions.

The exposome can be assessed through targeted biomonitoring of exposure
biomarkers. Currently, targeted biomonitoring is conducted by the Centers for Disease
Control and Prevention (CDC) through the National Health and Nutrition Examination
Survey (NHANES).11 As of 2019, 14 states have established their own biomonitoring
programs to monitor chemicals of local concern.12 These programs provide some
baseline data;13 however, the sample sizes are restricted and no longitudinal data on the
same participant is collected.14 A Million Marker-Renown Institute for Health Innovation
(RIHI) collaboration (MM-RIHI) could potentially monitor over 60,000 individuals enrolled
in Renown’s Healthy Nevada Project (HNP) and provide information such as location,
demographic, and lifestyle factors related to the exposome, as well as link the genomic
information to the exposomic information of these individuals. These individuals could
also be assessed over time to determine longitudinal changes, particularly with
interventions in lifestyle changes to reduce exposures. Because the MM kit and app are
easy to use, convenient, and non-invasive, a MM-RIHI collaboration could provide
ample data with minimal effort and risk.
The HNP is the largest community-based population health study in the world, with
more than 60,000 participants. This is twenty times larger than NHANES, the largest
nationwide population biomonitoring cohort. It’s also the first population health study to
return clinical results to study participants.
The collaboration between the Renown Institute for Health Innovation (RIHI) and Million
Marker would 1) increase biomarker collection and discovery and 2) increase the
exposure assessment database (both internal and external) conducted among existing
and future project participants. The HNP Project would be the largest population
environmental biomonitoring program in the world, and also the first one to report back
the biomonitoring results. As most of Million Marker’s current users are between the
ages of 25-44, this collaboration may help the HNP recruit younger participants. For
Million Marker, this collaboration would allow us to collect large amounts of
samples/data to further improve our existing platform, enable AI-assisted exposure
assessment and prediction, and drive long-term value for our users including the HNP
participants.
To initiate this collaboration, we are proposing a pilot to offer our service to individuals
within the participants in the HNP and/or through the Renown Healthcare system.
The aims of this pilot study are:
1) Test the feasibility of offering MM’s service to the HNP existing and future
participants
2) Collect pilot data and assess EDC levels among participants
3) Test the usability and perception of MM’s service among participants
4) Test whether offering MM’s service can lead to EDC reduction behaviors among
participants

5) Utilize pilot study data to prepare for larger research studies and grant
applications
2. Provide a detailed narrative, non-technical description of the project and of the
planned activity for the participants and/or data collection.
This project will assess the EDC exposure of participants, through urine testing and
self-administered journals. We will recruit up to 300 people (aged 18-40) from the
existing participants from the Healthy Nevada Project. Participants’ urine samples will
be collected via mail-in kits that will be sent to participants. Participants will follow Million
Marker’s current user journey that involves the following: 1) users receive MM’s test kits
in the mail, 2) take a comprehensive 24-hour food and product exposure survey via the
MM app, 3) collect their first void urine sample in the morning, 4) send back their
samples, 5) view their personalized reports with tailored product recommendations
through a secure online portal, 6) make changes to reduce their exposures, 7) test
again to track/monitor/confirm EDC levels if any behavioral changes have been made.
Participants can make changes to reduce their exposures according to the
recommendations in their personalized reports. Participants will receive a second test
kit three weeks after getting their initial reports, and be asked to complete and ship it
back within one week after receiving it in the mail. All participants will be offered the
second test kits as there will always be room for chemical reduction.
Participants will fill out the System Usability Scale (SUS) to evaluate the usability of the
Million Marker app and their experiences (engagement, satisfaction, and retention) upon
the recipient of their reports for both rounds of testing.
References:
1. Wild, C. P. Complementing the genome with an ‘exposome’: the outstanding
challenge of environmental exposure measurement in molecular epidemiology.
Cancer Epidemiol Biomark. Prev 14, 1847–50 (2005).
2. Wild, C. P. The exposome: from concept to utility. Int J Epidemiol 41, 24–32 (2012).
3. Rappaport, S. M. & Smith, M. T. Environment and Disease Risks. Science 330,
460–461 (2010).
4. Kelley, A. S. et al. Early pregnancy exposure to endocrine disrupting chemical
mixtures are associated with inflammatory changes in maternal and neonatal

circulation. Sci Rep 9, 5422 (2019).
5. Trasande, L. et al. Burden of disease and costs of exposure to endocrine disrupting
chemicals in the European Union: an updated analysis. Andrology 4, 565–72 (2016).
6. CDC. Bisphenol A (BPA) Factsheet. National Biomonitoring Program
https://www.cdc.gov/biomonitoring/BisphenolA_FactSheet.html (2017).
7. Harley, K. G. et al. Reducing Phthalate, Paraben, and Phenol Exposure from
Personal Care Products in Adolescent Girls: Findings from the HERMOSA
Intervention Study. Env. Health Perspect 124, 1600–1607 (2016).
8. Rochester, J. R. Bisphenol A and human health: a review of the literature. Reprod
Toxicol 42, 132–55 (2013).
9. Rochester, J. R., Bolden, A. L. & Kwiatkowski, C. F. Prenatal exposure to bisphenol
A and hyperactivity in children: a systematic review and meta-analysis. Env. Int 114,
343–356 (2018).
10. National Academies of Sciences Engineering and Medicine. Phthalates and Male
Reproductive-Tract Development. in Application of Systematic Review Methods in
an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active
Chemicals (eds. Division on Earth and Life Studies, Board on Environmental Studies
and Toxicology, & Committee on Endocrine-Related Low-Dose Toxicity) (National
Academies Press, 2017).
11. CDC. NHANES: National Health and Nutrition Examination Survey.
https://www.cdc.gov/nchs/nhanes/index.htm (2020).
12. CDC. State Biomonitoring Programs. National Biomonitoring Program
https://www.cdc.gov/biomonitoring/state_grants.html (2019).

13. CDC. Updated Tables, January 2019. National Report on Human Exposure to
Environmental Chemicals https://www.cdc.gov/exposurereport/index.html (2019).
14. CDC. National Center for Health Statistics National Health and Nutrition
Examination Survey Overview.
https://www.cdc.gov/nchs/data/nhanes/nhanes_13_14/NHANES_Overview_Brochur
e.pdf.
15. Attina, T. M. et al. Exposure to endocrine-disrupting chemicals in the USA: a
population-based disease burden and cost analysis. Lancet Diabetes Endocrinol. 4,
996–1003 (2016).