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OpenTrials
Completed

NCT Number: NCT02670382

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPA

Dietary Supplement

10 week supplementation

Other names: eicosapentaenoic acid

DHA

Dietary Supplement

10 week supplementation

Sunflower oil

Dietary Supplement

4-week lead-in

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2016
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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