Product UseNCT02471365
Study of Exposure to Chemicals in Consumer Products
An observational study of Product Use, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in the products they buy. It s not easy to measure them because the companies that sell the products don t have to tell the exact chemical ingredients. Read more about this study
- Who is it for?
- Ages 35 to 74 years, women only
- Conditions the study is for
- Product Use
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 12 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals will be recruited from the RTP area, since they will be required to complete home and clinic visits as part of their study participation.@@@@@@
Who may be able to join
- Individuals born female will be recruited for this study.
- Individuals must be between 35 and 74 years old at the time of enrollment.
- Individuals must be a non-smoker living in a non-smoking home. Individuals who are former smokers or live with a former smoker must be at least one year smoke free at the time of enrollment.
- Individuals must be non-pregnant and non-nursing at the time of enrollment.
- Individuals will not be selected for specific preexisting health conditions but will be excluded if any of the conditions described in Section 5.2 (EXCL 5) are present at the time of enrollment.
- Individuals who spend a majority of their time in the home each day will be recruited for this study. This includes individuals who work from home, are stay-at-home caretakers, retired, unemployed, etc.
- Individuals must use a high number of consumer products. A high consumer product user is someone who uses more than a certain number of products (e.g., 15 or more products a day). This number will be finalized following the completion of a separating screening activity by NIEHS under a separate IRB protocol, and will be defined prior to enrollment of participants in the study.
Who cannot join
- Persons born male or female-identifying transgender individuals will be excluded from the study population.
- Individuals younger than 35 years old or older than 74 years old will be excluded from the study population.
- Individuals who smoke, use tobacco products, or any form of electronic cigarettes, personal vaporizers, or electronic nicotine delivery systems will be excluded from the study population. Additionally, based on the pre-screening questionnaire individuals who live in homes with others who use one or more of these products will not be eligible to participate. Prescreening responses will be verified against cotinine test results from Screening Day 1
- Individuals who may be pregnant, are pregnant, or are nursing will be excluded from the study population.
- Individuals with chronic kidney or liver disease or insulin-dependent diabetics based on pre-screening questionnaire will not be eligible to participate in the study.
- Individuals who work outside of the home or spend a majority of their time each day outside of the home for other activities will be excluded from the study population.
- Individuals who use less than a certain number of consumer products (e.g., 15 products per day) will be excluded from the study population.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27713
About this study
Official title: NIEHS EPA Pilot Study of Exposure to Chemicals in Consumer Products
Background:
- In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in the products they buy. It s not easy to measure them because the companies that sell the products don t have to tell the exact chemical ingredients. Researchers want to compare how existing methods (e.g., surveys and models) measure exposure to chemicals in personal care and household products.
Read more
Objective:
- To test and improve the ways that studies gather data about contact with chemicals found in consumer products.
Eligibility:
- Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.
Design:
- Participants will be screened with medical history, pregnancy test, smoking test, and blood sample. They will answer questions about their homes and products they use.
- Participation will last about 30 hours over 12 days.
- Researchers will:
- Place air samplers inside and outside participants homes for 10 days. One sampler will need to be plugged into an electrical outlet. It will make a low, continuous sound while in operation.
- Collect house dust samples and record all consumer products in the house.
- Visit the house daily to collect samples.
- Participants will:
- Give a blood sample at a clinic twice.
- Collect all urine voids for 10 days. They will label it and put it in a special cooler.
- Wear 4 small devices that measure air pollution, chemicals, location, and activity.
- Record what they eat and what consumer products they use. They will write these in a diary and <TAB>photograph them on an iPhone provided to them.
- On day 2 of the study, they will collect a duplicate sample of what they eat.
- Take iPhone videos of their use of certain products.
- Answer questions about chemical ingredients in their personal care products.
Read the detailed description
Research to advance the characterization of environmental and chemical exposures through improved exposure assessments, at both the individual and population levels, is a research priority identified in the Strategic Research Action Plan for the U.S. Environmental Protection Agency (EPA) s Chemical Safety for Sustainability (CSS) program (EPA 2012) and the National Institutes of Environmental Health Sciences (NIEHS) Strategic Plan for 2012-2017 (NIEHS 2012). Leading up to the Strategic Plan, specific research priorities related to exposure assessment were identified in the 2011 NIEHS workshop Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects",
including the need to evaluate the utility of existing instruments that classify or quantify exposures, develop better tools to improve exposure assessment, and to better understand the nature of combined exposures (e.g., mixtures). This project will inform research priorities identified in the NIEHS strategic plan and several specific research needs discussed during the 2011 NIEHS workshop on mixtures, with a focus on assessing exposures from personal care and household products:
- Evaluate current exposure assessment technologies, including questionnaires
- Develop better models that link source with behavior to predict exposure
- Analyze combined exposures
- Evaluate usefulness of commercially available product use/marketing databases
- Evaluate prediction models
- Characterize behavior that impact exposures using new technologies (iPad/internet use)
Personal care products (PCPs) and other household/consumer products are of particular interest because of the efficiency of their delivery and widespread use. Exposure to chemicals in PCPs can result through either direct or indirect routes of contact depending on the use of the product (Dodson 2012; Koniecki et al. 2011; Rudel et al. 2003; Schettler 2006; Weschler and Nazaroff 2014). Health concerns exist about some chemicals found in PCPs and household setting. Over the course of a lifetime, the average consumer may encounter tens of thousands of chemicals used as ingredients in consumer products, many of which are proprietary; thus, getting a complete picture of the human exposome is challenging. Given the large number of co-occurring chemicals in these products, new strategies, tools, and
techniques need to be developed and evaluated for their utility in assessing exposure to the multitude (tens of thousands) of chemicals representing the reality of exposure. Innovative tools need to be evaluated for their potential contributions to exposure assessment through rapid, cost-efficient methods which allow the simultaneous measurement of multiple chemical agents and gathering of contextual information to inform exposure reduction. These integrated tools and techniques can then be used to refine measurement and predictive modeling methods that support high throughput chemical analysis and exposure assessment.
The proposed research concept represents collaboration between NIEHS (Division of the National Toxicology Program, Division of Intramural Research, and the Clinical Research Unit) and the EPA Office ofResearch and Development (ORD). The partnership includes co- funding with EPA, the sharing of equipment and expertise, and the use of EPA field teams for extensive collection of exposure information.
- Conditions
- Product Use
- Keywords
- Exposure Assessment, Questionnaire, Product Use, Biomonitoring, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Non-pregnant and non-nursing females between 35 and 74 who usesa high number (e.g., 15 or more products a day) of consumer products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint will be daily individual exposure estimates for each participant calculated through forward modeling of questionnaire data and environmental measurements and reverse modeling ofbiomarker data.
Measured: Ongoing
Secondary outcomes (1)
To evaluate the accuracy of historical consumer product usage questionnaires.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start7 Aug 2018
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Product UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kyla W Taylor, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471365
- Sponsor's protocol ID
- 150134
- Other IDs
- 15-E-0134
- Status last verified
- 8 Apr 2026
- First submitted
- 12 Jun 2015
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIEHS EPA Pilot Study of Exposure to Chemicals in Consumer Products
- ClinicalTrials.gov ID
- NCT02471365
- Acronym / sponsor ID
- 150134
- Conditions
- Product Use
- Keywords
- Exposure Assessment, Questionnaire, Product Use, Biomonitoring, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in the products they buy. It s not easy to measure them because the companies that sell the products don t have to tell the exact chemical ingredients. Researchers want to compare how existing methods (e.g., surveys and models) measure exposure to chemicals in personal care and household products.
Objective:
- To test and improve the ways that studies gather data about contact with chemicals found in consumer products.
Eligibility:
- Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.
Design:
- Participants will be screened with medical history, pregnancy test, smoking test, and blood sample. They will answer questions about their homes and products they use.
- Participation will last about 30 hours over 12 days.
- Researchers will:
- Place air samplers inside and outside participants homes for 10 days. One sampler will need to be plugged into an electrical outlet. It will make a low, continuous sound while in operation.
- Collect house dust samples and record all consumer products in the house.
- Visit the house daily to collect samples.
- Participants will:
- Give a blood sample at a clinic twice.
- Collect all urine voids for 10 days. They will label it and put it in a special cooler.
- Wear 4 small devices that measure air pollution, chemicals, location, and activity.
- Record what they eat and what consumer products they use. They will write these in a diary and <TAB>photograph them on an iPhone provided to them.
- On day 2 of the study, they will collect a duplicate sample of what they eat.
- Take iPhone videos of their use of certain products.
- Answer questions about chemical ingredients in their personal care products.
Detailed description
Research to advance the characterization of environmental and chemical exposures through improved exposure assessments, at both the individual and population levels, is a research priority identified in the Strategic Research Action Plan for the U.S. Environmental Protection Agency (EPA) s Chemical Safety for Sustainability (CSS) program (EPA 2012) and the National Institutes of Environmental Health Sciences (NIEHS) Strategic Plan for 2012-2017 (NIEHS 2012). Leading up to the Strategic Plan, specific research priorities related to exposure assessment were identified in the 2011 NIEHS workshop Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects",
including the need to evaluate the utility of existing instruments that classify or quantify exposures, develop better tools to improve exposure assessment, and to better understand the nature of combined exposures (e.g., mixtures). This project will inform research priorities identified in the NIEHS strategic plan and several specific research needs discussed during the 2011 NIEHS workshop on mixtures, with a focus on assessing exposures from personal care and household products:
- Evaluate current exposure assessment technologies, including questionnaires
- Develop better models that link source with behavior to predict exposure
- Analyze combined exposures
- Evaluate usefulness of commercially available product use/marketing databases
- Evaluate prediction models
- Characterize behavior that impact exposures using new technologies (iPad/internet use)
Personal care products (PCPs) and other household/consumer products are of particular interest because of the efficiency of their delivery and widespread use. Exposure to chemicals in PCPs can result through either direct or indirect routes of contact depending on the use of the product (Dodson 2012; Koniecki et al. 2011; Rudel et al. 2003; Schettler 2006; Weschler and Nazaroff 2014). Health concerns exist about some chemicals found in PCPs and household setting. Over the course of a lifetime, the average consumer may encounter tens of thousands of chemicals used as ingredients in consumer products, many of which are proprietary; thus, getting a complete picture of the human exposome is challenging. Given the large number of co-occurring chemicals in these products, new strategies, tools, and
techniques need to be developed and evaluated for their utility in assessing exposure to the multitude (tens of thousands) of chemicals representing the reality of exposure. Innovative tools need to be evaluated for their potential contributions to exposure assessment through rapid, cost-efficient methods which allow the simultaneous measurement of multiple chemical agents and gathering of contextual information to inform exposure reduction. These integrated tools and techniques can then be used to refine measurement and predictive modeling methods that support high throughput chemical analysis and exposure assessment.
The proposed research concept represents collaboration between NIEHS (Division of the National Toxicology Program, Division of Intramural Research, and the Clinical Research Unit) and the EPA Office ofResearch and Development (ORD). The partnership includes co- funding with EPA, the sharing of equipment and expertise, and the use of EPA field teams for extensive collection of exposure information.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Non-pregnant and non-nursing females between 35 and 74 who usesa high number (e.g., 15 or more products a day) of consumer products. |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals will be recruited from the RTP area, since they will be required to complete home and clinic visits as part of their study participation.@@@@@@
Key inclusion criteria (7 listed)
- Individuals born female will be recruited for this study.
- Individuals must be between 35 and 74 years old at the time of enrollment.
- Individuals must be a non-smoker living in a non-smoking home. Individuals who are former smokers or live with a former smoker must be at least one year smoke free at the time of enrollment.
- Individuals must be non-pregnant and non-nursing at the time of enrollment.
- Individuals will not be selected for specific preexisting health conditions but will be excluded if any of the conditions described in Section 5.2 (EXCL 5) are present at the time of enrollment.
Key exclusion criteria (7 listed)
- Persons born male or female-identifying transgender individuals will be excluded from the study population.
- Individuals younger than 35 years old or older than 74 years old will be excluded from the study population.
- Individuals who smoke, use tobacco products, or any form of electronic cigarettes, personal vaporizers, or electronic nicotine delivery systems will be excluded from the study population. Additionally, based on the pre-screening questionnaire individuals who live in homes with others who use one or more of these products will not be eligible to participate. Prescreening responses will be verified against cotinine test results from Screening Day 1
- Individuals who may be pregnant, are pregnant, or are nursing will be excluded from the study population.
- Individuals with chronic kidney or liver disease or insulin-dependent diabetics based on pre-screening questionnaire will not be eligible to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint will be daily individual exposure estimates for each participant calculated through forward modeling of questionnaire data and environmental measurements and reverse modeling ofbiomarker data.
Time frame: Ongoing
1 secondary outcome
To evaluate the accuracy of historical consumer product usage questionnaires.
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyla W Taylor, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Product Use, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint will be daily individual exposure estimates for each participant calculated through forward modeling of questionnaire data and environmental measurements and reverse modeling ofbiomarker data. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.