Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed… (NCT01442480) | Clinical Trial Compass
CompletedNot Applicable
Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles
United States29 participantsStarted 2009-06
Plain-language 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.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 50-75 years old generally healthy male and female.
* Normal resting electrocardiogram.
* Oxygen saturation greater than 94% at the time of physical exam.
Exclusion Criteria:
* 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.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart rate variability changes
Timeframe: pre-, immediately post-, and 20 hr post-air pollution exposure