Fish Oil and Biomarkers of Cardiovascular Risk

Study Overview
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Brief Summary
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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

Detailed Description
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N/A - withdrawn

Official Title
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Fish Oil and Biomarkers of Cardiovascular Risk

Conditions
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Cardiovascular Risk Factors

Intervention / Treatment
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* Dietary Supplement: fish oil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double Blind, Placebo Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dietary Supplement<br>Fish oil pill | Dietary Supplement: fish oil<br>* Fish oil pills will be taken daily for 12 weeks<br>* Other names: Omega-3 fatty acids;|
| Placebo Comparator: Placebo<br>Placebo matched corn oil pill | Dietary Supplement: Placebo<br>* Placebo (corn oil) will be taken daily for 12 weeks<br>* Other names: corn oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | 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. | every 2 weeks for a 12 week duration | 
| Heart Rate | Two-inch square adhesive patches will be used to monitor your heart rate | every two weeks for 12 week duration | 
| Arterial Pulse Wave Velocity | The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes. | every two weeks, for a 12 week duration | 
| Aortic Blood Pressure | Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist. | every two weeks, for a 12 week duration | 
| Brachial Artery Blood Flow | 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 | every two weeks, for a 12 week duration | 
| Brachial Artery Blood flow: After Nitroglycerin (0.4mg) | 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. | every two weeks, for a 12 week duration | 
| Microneurography | 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. | every two weeks, for a 12 week duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Withdrawal | An intravenous catheter will be inserted into veins near the elbow to collect blood for standard blood chemistry panel. | every two weeks, for a 12 week duration |