Recruiting

Innate

Sponsor:

National Institute of Environmental Health Sciences (NIEHS)

Code:

NCT01143480

Conditions

Asthma

Atherosclerosis

Metabolic Syndrome

Insulin Resistance

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

\- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers.

Objectives:

\- To examine how specific genes and proteins in blood cells respond to environmental exposures.

Eligibility:

\- Healthy volunteers between 18 and 45 years of age.

Design:

  • The study will involve one visit of 45 to 60 minutes.
  • Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking.
  • Participants will provide a blood sample for research purposes.

Conditions

Asthma

Atherosclerosis

Metabolic Syndrome

Insulin Resistance

Cancer

Study ID

NCT01143480

Start date

Jul 30, 2012

Status verified date

Mar 17, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • Male or female 18 years of age or older
  • Participants must be able to understand and provide written informed consent to participate in the study
  • Participants must be able to travel to the CRU
  • Willing and able to fast after midnight the night prior to their study appointment.
  • Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).

EXCLUSION CRITERIA:

  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)
  • Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit
  • Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)
  • Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)
  • Current treatment for cancer with chemotherapy or radiation
  • Confirmed or suspected immunosuppressive or immunodeficient condition
  • GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies
  • Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine >200 ng/mL at visit)
  • Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit
  • Body weight < 50 kg (<110 lbs)
  • Temperature > 37.6 C; blood pressure < 90/50 mm Hg or > 170/95 mm Hg; pulse rate < 50 or >100 beats/minute
  • Pregnant or suspected pregnancy
  • Chronic Kidney Disease

The PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.

Study Design

Enrollment

725 participants

Anticipated

Interventions and Outcome Measures

Arms

ABCA1

SNP or allele of interest

APOE

SNP or allele of interest

APOL1

SNP or allele of interest

CD14

SNP or allele of interest

CD44

SNP or allele of interest

IRGM

SNP or allele of interest

ITIH3

SNP or allele of interest

ITIH4

SNP or allele of interest

MyD88

SNP or allele of interest

TIRAP

SNP or allele of interest

TLR4

SNP or allele of interest

TLR5

SNP or allele of interest

TNFa

SNP or allele of interest

Primary outcome measure

  • The primary endpoints of this study are for both cell types and will be levels of 6 cytokines [TNF alpha, IL-6, MIP-2, IL-8, MCP-1, and IFN-beta (ELISA)] induced by LPS and by PAM3CSK4 plus baseline cytokine levels (no exposure to LPS or PAM3CSK... [ Time Frame: After analysis ]

Central Contacts and Locations

Central contacts

NIEHS Join A Study Recruitment Group

(855) 696-4347myniehs@nih.gov

Michael B Fessler, M.D.

(984) 287-4081fesslerm@niehs.nih.gov

Locations

NIEHS Clinical Research Unit (CRU)

Recruiting

Research Triangle Park, North Carolina, United States, 27709

Contacts

NIEHS Join A Study Recruitment Group

855-696-4347myniehs@nih.gov

More Information

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Last update posted

Aug 7, 2026

Last verified

Mar 17, 2026

Keywords

  • Endotoxin
  • Innate Immunity
  • Natural History
  • Healthy Volunteer
  • HV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS) on 2026-08-07.