Fish Oil and Biomarkers of Cardiovascular Risk

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

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Risk Factors
• Intervention / Treatment: Dietary supplement: fish oil; Dietary supplement: Placebo

Detailed Description

N/A - withdrawn

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Omega-3 fatty acids
Placebo Comparator: Placebo; Placebo matched corn oil pill	Dietary supplement: Placebo; Placebo (corn oil) will be taken daily for 12 weeks; Other Names: corn oil

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Kevin Monahan, PhD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 6, 2007
• First Submitted That Met QC Criteria: September 6, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 25918