Fish Oil and Biomarkers of Cardiovascular Risk

NCT ID: NCT00527436

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-09-30

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N/A - withdrawn

Conditions

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Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Double Blind, Placebo Controlled Trial
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dietary Supplement

Fish oil pill

Group Type OTHER

fish oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil pills will be taken daily for 12 weeks

Placebo

Placebo matched corn oil pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (corn oil) will be taken daily for 12 weeks

Interventions

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fish oil

Fish oil pills will be taken daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (corn oil) will be taken daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega-3 fatty acids corn oil

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Monahan, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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25918

Identifier Type: -

Identifier Source: org_study_id

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