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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00527436
Other study ID # 25918
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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N/A - withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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