An observational study in Inflammation, Normal Controls and Metabolic Disease, sponsored by National Institute of Environmental Health Sciences (NIEHS). Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
Background:
Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.
Objective:
To identify and understand how environmental exposures contribute to human disease.
Eligibility:
Healthy adults ages 18 and older
Design:
Participants will be screened with questions about their health history, demographics, and medicines they take.
Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.
Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.
Participants may have their nasal passages brushed, scraped, or washed.
Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup.
Participants who produce sperm may give samples.
Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.
Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests.
Participants may collect household dust, urine, or stool at home.
Participants will complete surveys about their health, diet, and exposures.
Participation will last for one or more study visits.
Participants may be contacted in the future to take part in other studies.
Study Description:
Environmental exposures such as pollution, diet, stress, etc. contribute to the development and exacerbation of human disease. Understanding the mechanisms of environmentally induced injury and inflammation will allow us to devise better prophylaxis and treatment measures.
Subjects may undergo sampling of (including but not limited to:) blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum etc., and may answer predefined questionnaires regarding health and exposures.
Studies which may be performed on collected material includes establishment of cell cultures and immunologic studies.
Objectives:
Primary Objective: To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Secondary Objectives: To develop better methodological tools in order to quantify host-environmental interactions in health and disease.
Endpoints:
Primary Endpoint: Biological markers of cell/tissue injury and inflammation, such as inflammatory cytokines, intracellular kinases or DNA/RNA damage in association with in vitro or in vivo environmental exposures.
Secondary Endpoints: Diseases or pathological processes (e.g. abnormal laboratory values) associated with environmental exposures.
763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 211 observational studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
Compared within Metabolic Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The general community sample will be from Durham, Raleigh, Chapel Hill and other nearby cities close to the NIEHS Clinical Research Unit (CRU).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Participants will be enrolled according to pre-defined host (e.g. disease, genetic, or demographic) or environmental (exposure) characteristics.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General public population, including females and males, who are over the age of 18, with a mixture of races and ethnicities representative of North Carolina.
To identify the interaction of host and environmental factors in the response to injury and the development of disease.
To identify the interaction of host and environmental factors in the response to injury and the development of disease.
Time frame: On-going
Plan to share: No — Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.
Started Nov 2021 (actual). Primary completion is estimated for Dec 2031, 121 months after the start.
Of 89 non-industry observational studies under Metabolic Diseases, half reached primary completion within 135 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 339. This study's planned 121 months is below that.
Counting every sponsor, half of 101 studies reached it within 135 months; a quarter within 23 and three quarters within 339.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Institute of Environmental Health Sciences (NIEHS) →