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

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ClinicalTrials.gov Identifier: NCT02670382
Recruitment Status : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Stefania lamon-Fava, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: EPA Dietary Supplement: DHA Dietary Supplement: sunflower oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism
Actual Study Start Date : March 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

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 Name: 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 for 10 weeks.
Dietary Supplement: sunflower oil
10 week supplementation




Primary Outcome Measures :
  1. interleukin-6 (IL-6) [ Time Frame: 10 weeks ]
    plasma levels in pg/mL

  2. Tumor necrosis factor alpha (TNF-alpha) [ Time Frame: 10 weeks ]
    plasma levels in pg/mL

  3. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: 10 weeks ]
    plasma levels in mg/dL

  4. high density lipoprotein cholesterol (HDL-C) [ Time Frame: 10 weeks ]
    plasma levels in mg/dL

  5. triglycerides [ Time Frame: 10 weeks ]
    plasma levels in mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670382


Locations
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United States, Massachusetts
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Stefania Lamon-Fava, PhD Tufts University

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Responsible Party: Stefania lamon-Fava, Scientist I, Associate Professor, Tufts University
ClinicalTrials.gov Identifier: NCT02670382     History of Changes
Other Study ID Numbers: 2845
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Additional relevant MeSH terms:
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Inflammation
Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases