EPA Human Studies Facility
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT02921048
This observational study recruits healthy individuals who have been routinely taking high amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating the cardiopulmonary effects of exposure to ambient air pollution.
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Notify Me25 year–55 year
All sexes
Observational
Chapel Hill, North Carolina, 27514, United States
Purpose: To examine the relationship between blood levels of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and cardiopulmonary responses to environmental air pollution in healthy adults. EPA and DHA are two important omega-3 fatty acids that are mainly found in seafoods and fish oils and associated with beneficial effects to human physiology.
Participants: Healthy 35-55 year-old male and female subjects will be screened for their dietary intake of EPA and DHA. Qualified volunteers will be divided into two groups, group 1: individuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months prior to enrollment in the study; group 2: individuals who have consumed no more than 1 serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil supplement during the 6 month period preceding enrollment.
Procedures (Methods): In this observational panel study, subjects will come to the U.S. EPA Human Studies Facility for up to 5 sessions, each consisting of 2 consecutive visit days. The following endpoints will be collected: blood pressure, heart rate variability measurements, blood biomarkers, endothelial cell function, retinal venule and arteriole diameter, and lung function. Air pollution exposure will be assessed using area-specific air quality data derived from local air monitoring stations interfaced with activity monitoring and GPS tracked location for each subject.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Temporary exclusion criteria:
Time frame: Sep. 2016 to Sep 2019
Time frame: Sep. 2016 to Sep 2019
Time frame: Sep. 2016 to Sep 2019
Time frame: Sep. 2016 to Sep 2019
Time frame: Sep. 2016 to Sep 2019
U.S. EPA Human Studies Facility
Fed
Acronym: PISCES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.