Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids

Study Overview
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Brief Summary
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The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.

Detailed Description
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This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.

Official Title
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Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: EPA
* Dietary Supplement: DHA
* Dietary Supplement: sunflower oil


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: fasting plasma TG levels between 150 and 500 mg/dL C-reactive protein (CRP) levels ≥2 µg/mL at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference >40 inches in men and >35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL. Exclusion criteria: high-fish diets (>2 fish meals/week) taking fish oil supplements or supplements containing EPA or DHA allergy to sardines allergy to sunflower oil regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids) anticoagulant therapy alcohol consumption >7 drinks/week uncontrolled thyroid dysfunction insulin-dependent type 2 diabetes mellitus kidney or liver disease smoking alterations in coagulation use of lipid altering medications

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA intervention<br>Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. | Dietary Supplement: EPA<br>* 10 week supplementation<br>* Other names: eicosapentaenoic acid;|
| Experimental: DHA intervention<br>Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. | Dietary Supplement: DHA<br>* 10 week supplementation<br>|
| Placebo Comparator: Placebo<br>3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase. | Dietary Supplement: sunflower oil<br>* 4-week lead-in<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 (IL-6) | plasma levels in pg/mL | 10 weeks | 
| Tumor Necrosis Factor Alpha (TNF-alpha) | plasma levels in pg/mL | 10 weeks | 
| Low Density Lipoprotein Cholesterol (LDL-C) | plasma levels in mg/dL | 10 weeks |