Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults

Completed

Conditions studied: Health Effects of Ambient Air Pollution

In brief

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.

Key facts

Study ID

NCT02921048

Run by

U.S. EPA Human Studies Facility

People needed

62

Starts

2016-09-15

Expected to finish

2019-11-15

Last updated by the study team

2022-05-10

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 25-55 years old healthy male and female (19≤BMI≤30).
• Normal resting ECG. No history of heart arrhythmia.
• Oxygen saturation greater than 96% at the time of physical exam.
• Taking at least 3 grams of EPA and DHA from dietary sources including fish oil supplements and ocean fish/shellfish for a 6 months or longer period of time preceding enrollment in the study; or taking 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 previous 6 months or longer period of time.

You may not qualify if…

• Individuals with a history of acute or chronic cardiovascular disease, such as myocardial infarction.
• Individuals with a history of chronic respiratory disease, such as COPD and asthma.
• Individuals with a history of cancer (possible exception for history of non-melanoma skin cancer).
• Uncontrolled hypertension (≥150 systolic, ≥90 diastolic).
• Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level >6.4%).
• Individuals who are currently smoking (including vaping, or using hookah or e cigarettes) or have a smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than/equal to a 5 pack year smoking history.
• Individuals living with a smoker who smokes inside the house.
• Individuals who are regularly exposed to high levels of vapors, dust, gases, or fumes.
• Individuals who do not understand or speak English.
• Individuals who are taking b-blocker medications.
• Individuals who are taking statins.
• Individuals that are unwilling or unable to maintain their current dietary pattern for the whole study.
• Individuals with bleeding or clotting disorders.
• Individuals who have active allergies.
• Individuals who have an allergy to latex, or skin allergy to tape or electrodes.
• Individuals who are pregnant or attempting to become pregnant.
• Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with clinical procedures will be a basis for exclusion.
• Individuals who are currently taking anti-depressants.
• Temporary exclusion criteria:
• Individuals who have had recent (within 6 months) abdominal and/or eye surgery, or been diagnosed with any type of hernia, as well as any other contraindications for raised intra-abdominal pressure.
• Individuals who have had an acute respiratory illness within 4 weeks.

Where it is running

• EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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