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

Summary

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.

Conditions

• Healthy
• Dietary Supplement

Interventions

DRUG

Ozone

After the four-week supplementation period, each subject will be blindly exposed on consecutive days to filtered air for 2 hours and to 0.3 ppm ozone for 2 hours, while undergoing intermittent moderate exercise (minute ventilation of 20 L/min/m²).

DIETARY_SUPPLEMENT

Fish Oil

3 (1-gram) soft-gels daily Commercially available, enteric-coated, soft-gels formulated to deliver \>60% eicosapentaenoic/docosahexaenoic acids (EPA/DHA)

DIETARY_SUPPLEMENT

Olive Oil

3 soft-gels daily Commercially available soft-gels containing 1 gram of USDA organic certified, cold pressed, extra virgin, olive oil

Sponsors & Collaborators

• Environmental Protection Agency (EPA)

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• James Samet, PhD · Environmental Protection Agency, University of North Carolina at Chapel Hil

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-18

Primary Completion

2020-12-18

Completion

2020-12-18

FDA Drug

Yes

Countries

• United States

Study Locations