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

Tufts University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: sunflower oil; Dietary Supplement: EPA; Dietary Supplement: DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT02670382

2845

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

EPA intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: EPA

DHA intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DHA

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: sunflower oil