clinical study to assess high-dha fish oil on biomarkers of cardiovascular disease risk in adults on statin therapy

Conditions: Cardiovascular Disease

Summary: the objective of this study is to determine the acute and chronic \[4-week\] effects of a high-dha fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on statin therapy.

this study involves fasted and post-prandial components. fasted study: participants will provide fasting blood samples pre-and post-intervention \[4-week administration of supplement or placebo\] in treatment period i. participants will again provide fasting blood samples pre-and post-intervention \[4-week administration of supplement or placebo, opposite to treatment period i\] during treatment period ii. there will be a 4-week washout period during the two treatment periods. post-prandial study: participants will also complete a post-prandial study pre-and post-intervention during each treatment period.

Eligibility criteria:
inclusion criteria: * be an adult between the ages of 18 and 70; * be a male or a post-menopausal female who has gone a minimum of one year since their last menses; * be taking statin medication at a stable dose for a minimum of four weeks prior to study commencement \[and whom have reached a target ldl level\]; * have elevated fasting triglyceride levels \[greater than 1.5 mmol/l but less than 5.7 mmol/l\]; * have fasting blood glucose levels below the study cut-off \[less than 7.0 mmol/l\]; * have a body mass index (bmi) less than 35.0 * be taking natural health products but agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement. exclusion criteria: * be younger than 18 years of age or older than 70 years of age; * be an adult pre- or peri-menopausal female; * not have taken statin medication at a stable dose for a minimum of 4 weeks prior to study commencement; * have fasting triglyceride levels outside of study limits\[ie/ less than 1.5 mmol/l or greater than 5.7 mmol/l\]; * have elevated fasting blood glucose levels \[greater or equal to 7.0 mmol/l\]; * have high blood pressure \[greater than 140/100\] * have a body mass index (bmi) equal to or greater than 35.0 * have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack; * have a known allergy to fish and/or fish oil, olive oil, soy or vitamin e; * be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement; * consume more than two (2) fish meals on a weekly basis * consume excessive amounts of alcohol on a weekly basis \[more than 10 alcoholic drinks per week\]; * anticipate or have planned surgery during the course of the study.

Keywords: humans cardiovascular disease statins fish oil dha epa high-dha triglycerides total cholesterol [tc] lipoproteins high-density lipoprotein [hdl2, hdl3] low-density lipoprotein [ldl1+2+3+4] lipoprotein a [lp(a)] intermediate-density lipoprotein (idl) very low-density lipoprotein (vldl1+2, vldl3) remnant lipoproteins high-sensitivity c-reactive protein [hs-crp] homocysteine essential fatty acid profile apolipoprotein b apolipoprotein a-1 glucose insulin fasted post-prandial