HealthyNCT01442480
Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles
A study testing Fish oil and Olive oil in people with Healthy, run by Environmental Protection Agency (EPA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fish oil and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75 years old generally healthy male and female.
- Normal resting electrocardiogram.
- Oxygen saturation greater than 94% at the time of physical exam.
Who cannot join
- 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.
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- History of bleeding diathesis.
- Currently taking beta-blockers to control hypertension and/or arrhythmias.
- Use of oral anticoagulants.
- Participants must refrain from all over-the-counter nonsteroidal anti-inflammatory drugs for a period of two weeks prior to exposure. Low-dose aspirin will be acceptable. Medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study.
- 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.
- Subjects who are currently smoking or have smoking history within 1 year of study (defined as more than one pack of cigarettes in the past year) or have a greater than/equal to a 5 pack year smoking history.
- No exposure will be conducted within 2 weeks of a respiratory tract infection.
- Subject is pregnant, attempting to become pregnant or breastfeeding.
- Unspecified illnesses, which in the judgment of the investigators might increase the risk associated with PM inhalation will be a basis for exclusion.
- Have an allergy to latex.
- History of skin allergy to tape or electrodes.
Trial locations and contacts
1 site in 1 country.
United States1 site
EPA Human Studies Facility
Chapel Hill, North Carolina, 27514
About this study
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
- Being tested
- Fish oil, Olive oil
- Keywords
- air pollution, fatty acid supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary 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.
Olive oilDietary supplement
Subjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d.
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Not described Receives: Dietary Supplement: Fish oil |
| Olive oil | Experimental | Not described Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability changes
Measured: 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
Measured: pre-, immediately post-, and 20 hr post-air pollution exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Environmental Protection Agency (EPA)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Haiyan Tong, Environmental Protection Agency (EPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442480
- Sponsor's protocol ID
- Omegacon
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2011
- Last updated
- 8 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles
- ClinicalTrials.gov ID
- NCT01442480
- Acronym / sponsor ID
- Omegacon
- Conditions
- Healthy
- Keywords
- air pollution, fatty acid supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Environmental Protection Agency (EPA)US federal agency
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Fish oil |
| Olive oil | Experimental | Dietary Supplement: Olive oil |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75 years old generally healthy male and female.
- Normal resting electrocardiogram.
- Oxygen saturation greater than 94% at the time of physical exam.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilSubjects (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. | Dietary supplement | Fish oil |
| Olive oilSubjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d. | Dietary supplement | Olive oil |
Primary outcome
Heart rate variability changes
Time frame: pre-, immediately post-, and 20 hr post-air pollution exposure
1 secondary outcome
endothelial function changes measured by flow-mediated dilation of the brachial artery
Time frame: pre-, immediately post-, and 20 hr post-air pollution exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and Olive oil in people with Healthy, run by Environmental Protection Agency (EPA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability changes (time frame: pre-, immediately post-, and 20 hr post-air pollution exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.