Cardiovascular Risk Factors
Conditions
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
Detailed description
N/A - withdrawn
Interventions
DIETARY_SUPPLEMENTfish oil
Fish oil pills will be taken daily for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo (corn oil) will be taken daily for 12 weeks
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, Double Blind, Placebo Controlled Trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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: 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. |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed