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

NCT03395119 | Completed Phase 1 FDA Drug

• 1 other identifier: 15-2960
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ozone exposure; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Change in forced expired volume in the first second (FEV1) from air exposure (Day 1) to ozone exposure (Day 2)

  FEV1 is determined by spirometry

  Day 1, Day 2

Secondary Outcomes (14)

• endothelial cell function 1 hour post-exposure

  1 hour pre-exposure, 1 hour post-exposure

• endothelial cell function 18 hour post-exposure

  1 hour pre-exposure, 18 hour post-exposure

• diameters of retinal arteries and veins 1 hour post-exposure

  30 min pre-exposure, 1 hour post-exposure

• diameters of retinal arteries and veins 18 hour post-exposure

  30 min pre-exposure, 18 hour post-exposure

• airway inflammation 4 hour post-exposure

  6 weeks prior to the exposure, 4 hour post-exposure

Study Arms (3)

No Supplements

SHAM COMPARATOR

The control group includes 20 healthy volunteers who will receive no supplements in the study. 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

Drug: Ozone

Fish oil

EXPERIMENTAL

Twenty healthy young adults will receive fish oil supplements for 4 weeks. 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

Drug: Ozone; Dietary Supplement: Fish Oil

Olive oil

EXPERIMENTAL

Twenty healthy young adults will receive olive oil supplements for 4 weeks. 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

Drug: Ozone; Dietary Supplement: Olive Oil

Interventions

Ozone DRUG

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).

Also known as: Filtered air

Fish oil; No Supplements; Olive oil

Fish Oil DIETARY_SUPPLEMENT

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

Also known as: omega-3 fatty acids (eicosapentaenoic/docosahexaenoic)

Fish oil

Olive Oil DIETARY_SUPPLEMENT

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

Also known as: extra virgin olive oil

Olive oil

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Environmental Protection Agency (EPA): collaborator

Study Sites (1)

U.S. Environmental Protection Agency Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Ozone; Fish Oils; Fatty Acids, Omega-3; Olive Oil

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• James Samet, PhD

  Environmental Protection Agency, University of North Carolina at Chapel Hil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigators are blinded for the assignment of dietary supplementation of fish oil, olive oil or control.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 10, 2018
• Study Start: December 18, 2017
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available in ScienceHub after the publication of the study is completed.
• Access Criteria: Data will be available to the public

Locations

US (1)