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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670382
• Other study ID #: 2845
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2020

Study information

• Verified date: April 2021
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome

Intervention

Dietary Supplement:
• EPA
10 week supplementation
• DHA
10 week supplementation
• sunflower oil
4-week lead-in

Locations

Country	Name	City	State
United States	Jean Mayer Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (IL-6)	plasma levels in pg/mL	10 weeks
Primary	Tumor Necrosis Factor Alpha (TNF-alpha)	plasma levels in pg/mL	10 weeks
Primary	Low Density Lipoprotein Cholesterol (LDL-C)	plasma levels in mg/dL	10 weeks