Fish Oil and Biomarkers of Cardiovascular Risk

Cardiovascular Risk Factors Clinical Trial

Official title:

Fish Oil and Biomarkers of Cardiovascular Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527436
• Other study ID #: 25918
• Status: Terminated
• Phase: N/A
• Start date: September 2007
• Est. completion date: September 2007

Study information

• Verified date: April 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

N/A - withdrawn

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

Dietary Supplement:
• fish oil
Fish oil pills will be taken daily for 12 weeks
• Placebo
Placebo (corn oil) will be taken daily for 12 weeks

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urine collection	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	24 hours
Primary	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
Primary	Heart Rate	Two-inch square adhesive patches will be used to monitor your heart rate	every two weeks for 12 week duration
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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