NCT00527436

Fish Oil and Biomarkers of Cardiovascular Risk

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Accepted

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N/A - withdrawn

Conditions

• Cardiovascular Risk Factors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-09-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: United States