Clinical trial NCT00527436: Fish Oil and Biomarkers of Cardiovascular Risk
Official title: Fish Oil and Biomarkers of Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Risk Factors
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double Blind, Placebo Controlled Trial
Primary purpose: OTHER

Brief 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

Detailed description: N/A - withdrawn

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: every 2 weeks for a 12 week duration
measure: Heart Rate
timeFrame: every two weeks for 12 week duration
measure: Arterial Pulse Wave Velocity
timeFrame: every two weeks, for a 12 week duration
measure: Aortic Blood Pressure
timeFrame: every two weeks, for a 12 week duration
measure: Brachial Artery Blood Flow
timeFrame: every two weeks, for a 12 week duration
measure: Brachial Artery Blood flow: After Nitroglycerin (0.4mg)
timeFrame: every two weeks, for a 12 week duration
measure: Microneurography
timeFrame: every two weeks, for a 12 week duration
Secondary outcomes:
measure: Blood Withdrawal
timeFrame: every two weeks, for a 12 week duration
Other outcomes:
measure: Urine collection
timeFrame: 24 hours
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kevin Monahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: