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Fish Oil and Biomarkers of Cardiovascular Risk

NCT00527436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-04-10

No results posted yet for this study

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

Conditions

  • Cardiovascular Risk Factors

Interventions

DIETARY_SUPPLEMENT

fish oil

Fish oil pills will be taken daily for 12 weeks

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Kevin Monahan, PhD · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527436 on ClinicalTrials.gov