Fish Oil and Biomarkers of Cardiovascular Risk
|ClinicalTrials.gov Identifier: NCT00527436|
Recruitment Status : Unknown
Verified September 2007 by Penn State University.
Recruitment status was: Not yet recruiting
First Posted : September 10, 2007
Last Update Posted : September 10, 2007
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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascualr Risk Factors||Dietary Supplement: fish oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Fish Oil and Biomarkers of Cardiovascular Risk|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527436
|United States, Pennsylvania|
|Penn State College of Medicine||Not yet recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Kevin Monahan, PhD||Penn State College of Medicine|