Fish Oil and Biomarkers of Cardiovascular Risk

Penn State Health

Status: Terminated

Conditions: Cardiovascular Risk Factors

Treatments: Dietary Supplement: Placebo; Dietary Supplement: fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00527436

25918

Details and patient eligibility

About

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

Full description

N/A - withdrawn

Enrollment: 3 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Dietary Supplement

Other group

Description:

Fish oil pill

Treatment:

Dietary Supplement: fish oil

Placebo

Placebo Comparator group

Description:

Placebo matched corn oil pill

Treatment:

Dietary Supplement: Placebo