Trials / Completed
CompletedNCT02921048
Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (actual)
- Sponsor
- U.S. EPA Human Studies Facility · Federal
- Sex
- All
- Age
- 25 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | omega-3 fatty acids |
Timeline
- Start date
- 2016-09-15
- Primary completion
- 2019-11-15
- Completion
- 2019-11-15
- First posted
- 2016-09-30
- Last updated
- 2022-05-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02921048. Inclusion in this directory is not an endorsement.