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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: EPA; Dietary supplement: DHA; Dietary supplement: sunflower oil

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPA intervention; 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; 10 week supplementation; Other Names: eicosapentaenoic acid
Experimental: DHA intervention; 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; 10 week supplementation
Placebo Comparator: Placebo; 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; 4-week lead-in

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Stefania Lamon-Fava, PhD, Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Inflammation; Metabolic Syndrome
• Other Study ID Numbers: 2845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The objective of this study is to provide critical information regarding both common and distinctive roles of the omega-3 fatty acids EPA and DHA in systemic inflammation and lipid metabolism.