Vascular and Lipid Effects of Omega-3 Fatty Acids in People With Moderately Elevated Triglycerides

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Official Title
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Omacor: Measures of Endothelial Function and triGlyceride Alteration

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: 4/day of 4g P-OM3 capsules
* Drug: 4/day of 1g P-OM3 capsules
* Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: triglycerides 150-500 mg/dL age 21-65 years generally healthy body mass index (BMI) 20-39 kg/m2 Exclusion Criteria: smoking premenopausal (if female) use of hormone replacement or oral contraceptives use of lipid lowering or blood pressure medication hypertension (blood pressure > 150/95 mm Hg) peripheral vascular disease heart disease, diabetes, or stroke inflammatory disease (e.g. rheumatoid arthritis or Crohn's) elevated liver enzymes high intake of omega-3 containing foods allergy to adhesive or latex use of aspirin, anticoagulants, or SSRI

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4g P-OM3, then 1g P-OM3, then Placebo<br>4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks). | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|
| Experimental: 1g P-OM3, then 4g P-OM3, then Placebo<br>1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks. | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|
| Experimental: Placebo, then 4g P-OM3, then 1g P-OM3<br>Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks. | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|
| Experimental: 4g P-OM3, then Placebo, then 1g P-OM3<br>4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks. | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|
| Experimental: 1g P-OM3, then Placebo, then 4g P-OM3<br>1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|
| Experimental: Placebo, then 1g P-OM3, then 4g P-OM3<br>Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. | Drug: 4/day of 4g P-OM3 capsules<br>* 4/day of 4g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: 4/day of 1g P-OM3 capsules<br>* 4/day of 1g P-OM3 capsules for 8 weeks<br>* Other names: Fish oil;Drug: Corn Oil Placebo, 4 capsules/day for 8 weeks<br>* 4 capsules per day of corn oil placebo for 8 weeks<br>* Other names: Corn oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile | Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol. | 8 weeks | 
| Flow-mediated Dilation (FMD) | Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period. | 8 weeks | 
| Blood Pressure | Effect of P-OM3 dose on blood pressure | 8 weeks | 
| Heart Rate | Effect of P-OM3 dose on heart rate | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte Fatty Acids | Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells | 8 weeks | 
| Cytokine Inflammatory Markers | Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma | 8 weeks | 
| Fasting Glucose | Effect of P-OM3 dose on fasting glucose | 8 weeks | 
| Psychosocial Profile Questionnaires | Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS) 14 questions, scored 0-4 based on how often the subject felt certain emotions Scores: 0 to 40; higher scores indicate higher perceived stress Spielberger State Anxiety Inventory Levels of state anxiety (situational) and trait anxiety; 40 items scored by a Likert scale Scores: 20 to 80; higher scores indicate higher levels of anxiety Positive and Negative Affect Scales (PANAS) Two 10-item scales; each item is rated on a Likert scale of 1 (not at all) to 5 (very much). Scores: 10 to 50, with higher scores representing higher levels of positive or negative affect Center for Epidemiologic Studies Depression (CES-D) Scale 20 questions about symptoms of depression in the past week Scores: 0 to 60; higher scores indicate more symptomology. Score of 16 or higher indicates a risk for depression and should be followed by further evaluation by a qualified health professional | 8 weeks | 
| C-reactive Protein (CRP) | Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP | 8 weeks | 
| Fasting Insulin | Effect of P-OM3 dose on fasting insulin | 8 weeks | 
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) | Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3, DHA, triglycerides, hypertriglyceridemia, omega-3, eicosapentaenoic acid, EPA, docosahexaenoic acid, flow mediated dilation, fish, Moderate hypertriglyceridemia