- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442480
Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles
September 27, 2011 updated by: Haiyan Tong, Environmental Protection Agency (EPA)
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- EPA Human Studies Facility
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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, 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish oil
|
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.
|
Experimental: Olive oil
|
Subjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate variability changes
Time Frame: pre-, immediately post-, and 20 hr post-air pollution exposure
|
pre-, immediately post-, and 20 hr post-air pollution exposure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endothelial function changes measured by flow-mediated dilation of the brachial artery
Time Frame: pre-, immediately post-, and 20 hr post-air pollution exposure
|
pre-, immediately post-, and 20 hr post-air pollution exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
September 26, 2011
First Submitted That Met QC Criteria
September 27, 2011
First Posted (Estimate)
September 28, 2011
Study Record Updates
Last Update Posted (Estimate)
September 28, 2011
Last Update Submitted That Met QC Criteria
September 27, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Omegacon
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Fish oil
-
University of CopenhagenAnjo A/SCompletedObesity | Cardiovascular Disease | Metabolic Syndrome | Growth | Blood Pressure
-
DSM Nutritional Products, Inc.Completed
-
Rigshospitalet, DenmarkDanish Child Cancer FoundationRecruitingLeukemia, Acute LymphoblasticDenmark
-
National Science Council, TaiwanCompletedMajor Depressive DisorderTaiwan
-
Tufts UniversityPrevention PharmaceuticalsTerminated
-
Liverpool John Moores UniversityCompleted
-
Stanford UniversityNordic NaturalsCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedProteomics | Lipoprotein Metabolism | PCSK9United States
-
National Heart, Lung, and Blood Institute (NHLBI)UnknownMyocardial Tissue in Heart Transplantation
-
Melbourne HealthCompleted