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

NCT ID: NCT02670382

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-10-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

EPA

Intervention Type: DIETARY_SUPPLEMENT

10 week supplementation

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.

Group Type: EXPERIMENTAL

DHA

Intervention Type: DIETARY_SUPPLEMENT

10 week supplementation

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.

Group Type: PLACEBO_COMPARATOR

sunflower oil

Intervention Type: DIETARY_SUPPLEMENT

4-week lead-in

Interventions

EPA

10 week supplementation

Intervention Type: DIETARY_SUPPLEMENT

DHA

10 week supplementation

Intervention Type: DIETARY_SUPPLEMENT

sunflower oil

4-week lead-in

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

eicosapentaenoic acid

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Stefania lamon-Fava

Scientist I, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefania Lamon-Fava, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2845

Identifier Type: -

Identifier Source: org_study_id