Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects

Completed · Phase 1

Conditions studied: Healthy, Dietary Supplement

In brief

Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollution. One of the common air pollutants, ozone, has been shown to induce oxidative stress and inflammation in the cardiovascular and respiratory systems. This proposed study is to examine the efficacy of fish oil and olive oil in modulating cardiovascular and pulmonary functions after ozone exposure. The objective is to understand the mechanistic basis for the health effects of ozone relative to those air pollutants. Treatment groups will include forty healthy young adults who will be given dietary supplementation of fish oil or olive oil. A control group will consist of 20 healthy volunteers who will receive no supplements. After 4 weeks, subjects will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day. Cardiac rhythm, pulmonary function, vascular responses, endothelial function, and markers of coagulation and airway inflammation pre- and post- ozone exposure will be measured. This study is designed to build on the previous nutritional supplement interventional studies (UNC IRB # 07-0190 and UNC IRB # 11-1807), in order to understand the mechanism of action of particulate pollutants in comparison to that of ozone, a known oxidant air contaminant. Participants: A total of sixty healthy 18-35 year-old male and female subjects will be involved in the study. Procedures (methods): Forty healthy young adults will receive dietary supplementation consisting of fish oil or olive oil for 4 weeks. The control group includes 20 healthy volunteers who will receive no supplements in the study. After 4 weeks of supplementation or control regiment, each subject will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day.

Key facts

Study ID: NCT03395119
Run by: University of North Carolina, Chapel Hill
People needed: 44
Starts: 2017-12-18
Expected to finish: 2020-12-18
Last updated by the study team: 2021-01-15

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 18-35 years old healthy male and female (19≤BMI≤30).
Physical conditioning allowing intermittent, moderate exercise for 2 hours, and ability to complete the exposure exercise regimen chosen to induce a minute ventilation rate of 20 L/min/m² for 15 minutes without exceeding 80% of predicted maximal heart rate.
Normal resting electrocardiography (ECG)
Normal lung function
Oxygen saturation greater than 94% at the time of physical exam.
Individuals whose blood omega-3 index is 5% or lower at the time of screening.

You may not qualify if…

Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, cancer (possible exception for history of non-melanoma skin cancer), rheumatologic disease, neuromuscular disease, or immunodeficiency state.
Individuals with a cardiovascular disease risk score greater than 10% using the American College of Cardiology and the American Heart Association Atherosclerotic Cardiovascular Disease risk calculator. (Based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular risk.)
Uncontrolled hypertension (>150 systolic, >90 diastolic).
Individuals who are diabetic (previously diagnosed or with hemoglobin A1c level >6.4%).
Individuals with asthma or a history of asthma.
Individuals who are allergic to chemical vapors or gases.
Individuals who have skin allergy to tape or electrodes.
Individuals is pregnant, attempting to become pregnant or breastfeeding.
Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have 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 that do not understand or speak English.
Individuals that are unable to perform the exercise required for the study.
Individuals who are taking Î2-blocker medications.
Individuals who are allergic to fish or omega-3 fatty acids, or are on prescription of taking omega-3 fish oil as therapy.
Individuals that are unwilling or unable to stop taking medications that may impact the results of ozone challenge for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to an individuals inclusion in the study.
Individuals who are unwilling or unable to stop taking any current dietary supplements for the duration of the study. Prebiotics and probiotics are acceptable.
Individuals who are unwilling or unable to adhere to study specific dietary restrictions (see details under A.4.2 dietary instruction).
Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with ozone inhalation will be a basis for exclusion.
Individuals with bleeding/clotting disorders.
Individuals who are not willing to participate the induced sputum procedure on the training day.
Temporary exclusion criteria:
Individuals who have recent (within 6 month) abdominal and/or eye surgery, or with any types of hernia, as well as any other contraindications for raised intra-abdominal pressure.
Individuals who have had an acute respiratory illness within 4 weeks.
Individuals who are currently taking systemic steroids, oral anticoagulants, over-the counter pain medications (such as aspirin, Advil, Aleve) or nonsteroidal anti-inflammatory drugs, or have taken these medications within the last 14 days.

Where it is running

U.S. Environmental Protection Agency Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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