Cardiovascular Risk Factors Clinical Trial
Official title:
Fish Oil and Biomarkers of Cardiovascular Risk
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
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