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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EPA
DHA
sunflower oil
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EPA intervention

DHA intervention

Placebo

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 23, 2015
Last Updated
April 13, 2021
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT02670382
Brief Title
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
Official Title
Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPA intervention
Arm Type
Experimental
Arm 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.
Arm Title
DHA intervention
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA
Other Intervention Name(s)
eicosapentaenoic acid
Intervention Description
10 week supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Intervention Description
10 week supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
sunflower oil
Intervention Description
4-week lead-in
Primary Outcome Measure Information:
Title
Interleukin-6 (IL-6)
Description
plasma levels in pg/mL
Time Frame
10 weeks
Title
Tumor Necrosis Factor Alpha (TNF-alpha)
Description
plasma levels in pg/mL
Time Frame
10 weeks
Title
Low Density Lipoprotein Cholesterol (LDL-C)
Description
plasma levels in mg/dL
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania Lamon-Fava, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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