Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles

NCT01442480 | Completed

• 1 other identifier: Omegacon
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality. Advanced age is among the factors associated with susceptibility to the adverse effects of air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular risk through multiple mechanisms. This study evaluated the efficacy of supplementation with marine fish oil or olive oil in protecting against cardiovascular effects induced by controlled exposure of middle-aged healthy volunteers to concentrated ambient air pollution particles. Subjects (ages 50 to72 years), were randomly assigned to receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or olive oil (3g/d) for 28 d. Subjects were then exposed to concentrated ambient air pollution particles or filtered air for 2 hr on sequential days. Heart rate variability (HRV), plasma lipids, coagulation markers, and endothelial function measured by flow-mediated dilation of the brachial artery (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.

Conditions

Healthy

Keywords

air pollution; fatty acid supplementation

Outcome Measures

Primary Outcomes (1)

• Heart rate variability changes

  pre-, immediately post-, and 20 hr post-air pollution exposure

Secondary Outcomes (1)

• endothelial function changes measured by flow-mediated dilation of the brachial artery

  pre-, immediately post-, and 20 hr post-air pollution exposure

Study Arms (2)

Fish oil

EXPERIMENTAL

Dietary Supplement: Fish oil

Olive oil

EXPERIMENTAL

Dietary Supplement: Olive oil

Interventions

Fish oil DIETARY_SUPPLEMENT

Subjects (ages 50 to 75 years), were randomly assigned to receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid) for 28 d.

Fish oil

Olive oil DIETARY_SUPPLEMENT

Subjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d.

Olive oil

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-75 years old generally healthy male and female.
• Normal resting electrocardiogram.
• Oxygen saturation greater than 94% at the time of physical exam.

You may not qualify if:

• A history of angina, cardiac arrhythmias, congestive heart failure, and ischemic myocardial infarction or coronary bypass surgery.
• Cardiac pacemaker.
• Uncontrolled hypertension (\> 150 systolic, \> 90 diastolic).
• Neurodegenerative diseases such as Parkinson's and Alzheimer disease.
• A history of chronic illnesses such as diabetes, cancer (possible exception for history of nonmelanoma skin cancer), rheumatologic diseases, immunodeficiency state, significant chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma.
• A history of migraine headache.
• History of bleeding diathesis.
• Currently taking beta-blockers to control hypertension and/or arrhythmias.
• Use of oral anticoagulants.
• Allergies to fish or omega-3 fatty acids.
• Subjects are on prescriptions taking omega-3 fish oil as therapy.
• Subjects will be required to avoid taking omega-3 fatty acids or having more than one 4-6 oz/serving of all types of fish and shellfish, walnuts, flaxseeds and flaxseed oil, rapeseed oil, canola oil, soybeans and soy products, omega-3 fortified eggs, and cod liver oil for two weeks before and during the study.
• Subjects will be required to avoid taking antioxidants (e.g., beta-carotene, selenium, vitamin C, vitamin E, zinc) for two weeks before and during the study.
• Subjects will be required to use olive oil exclusively for cooking, dressings, and sauces during the study and to avoid other vegetable oils because of their omega-3 contents.
• Because of reported cardioprotective effects of red wine, subjects will be required to avoid drinking red wine during the study.

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead

Study Sites (1)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Interventions

Fish Oils; Olive Oil

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2016
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)