Fish Oil and Biomarkers of Cardiovascular Risk
Study Details
Study Description
Brief Summary
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development.
Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk.
Study Population Healthy young (18-40 years of age) and older (50-79) men and women.
Major Inclusion & Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.
Allocation to Groups Randomized, double-blinded, and placebo-controlled.
Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
N/A - withdrawn
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Dietary Supplement Fish oil pill |
Dietary Supplement: fish oil
Fish oil pills will be taken daily for 12 weeks
Other Names:
|
| Placebo Comparator: Placebo Placebo matched corn oil pill |
Dietary Supplement: Placebo
Placebo (corn oil) will be taken daily for 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Blood Pressure [every 2 weeks for a 12 week duration]
Blood pressure will be measured using a cuff placed around the subject's upper arm as well as a small cuff placed on their finger.
- Heart Rate [every two weeks for 12 week duration]
Two-inch square adhesive patches will be used to monitor your heart rate
- Arterial Pulse Wave Velocity [every two weeks, for a 12 week duration]
The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes.
- Aortic Blood Pressure [every two weeks, for a 12 week duration]
Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist.
- Brachial Artery Blood Flow [every two weeks, for a 12 week duration]
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after deflation of a blood pressure cuff that previously had been inflated tightly on the upper forearm for a period of 5 minutes
- Brachial Artery Blood flow: After Nitroglycerin (0.4mg) [every two weeks, for a 12 week duration]
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after placing a pill containing nitroglycerin (0.4mg) under the tongue.
- Microneurography [every two weeks, for a 12 week duration]
Two very fine, sterile nerve wires (micro-electrodes), thinner than a sewing needle, will be introduced through the skin into a nerve located just under the skin of the right leg. This procedure will measure nerve activity from the brain to the leg.
Secondary Outcome Measures
- Blood Withdrawal [every two weeks, for a 12 week duration]
An intravenous catheter will be inserted into veins near the elbow to collect blood for standard blood chemistry panel.
Other Outcome Measures
- Urine collection [24 hours]
The subject will be asked to collect urine over the course of one day (24 hours) in a jug provided. The urine will be analyzed for catecholamine levels
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must be healthy (as assessed by history and physical examination:
-
Non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results.
-
Women must be non-pregnant.
-
Normal liver enzymes (ALT and AST).
Exclusion Criteria:
- Individuals with allergies to corn will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn State College of Medicine | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Kevin Monahan, PhD, Penn State College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 25918