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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: EPA; Dietary Supplement: sunflower oil; Dietary Supplement: DHA

• Registration Number: NCT02670382
• Lead Sponsor: Tufts University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-01
• Study Start: 2016-03
• Primary Completion: 2020-05
• Study Completion: 2020-10
• Results First Submitted: 2021-02-26
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-13
• Last Update Submitted: 2021-04-13
• Results First Posted: 2021-04-14
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EPA intervention	EPA	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.
Placebo	sunflower oil	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.
DHA intervention	DHA	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States