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Study Comparing Fish Oil and Krill Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670356
Recruitment Status : Terminated (Study stopped by the company funding the study)
First Posted : February 1, 2016
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Prevention Pharmaceuticals
Information provided by (Responsible Party):
Stefania lamon-Fava, Tufts University

Brief Summary:
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Inflammation Dyslipidemia Dietary Supplement: Fish oil Dietary Supplement: Krill oil Not Applicable

Detailed Description:

Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.

Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).

The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Comparing Fish Oil and Krill Oil
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Fish oil
fish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks
Dietary Supplement: Fish oil
two 750 mg/capsules/day

Experimental: krill oil
krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks
Dietary Supplement: Krill oil
one 300 mg capsule/day




Primary Outcome Measures :
  1. Omega-3 index [ Time Frame: 10 weeks ]
    red blood cell membrane levels of EPA and DHA, as percent of total fatty acids


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

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

  3. Monocyte chemoattractant protein 1 (MCP-1) [ Time Frame: 10 weeks ]
    plasma levels as pg/mL

  4. Total cholesterol [ Time Frame: 10 weeks ]
    plasma levels as mg/dL

  5. LDL cholesterol [ Time Frame: 10 weeks ]
    plasma levels as mg/dL

  6. HDL cholesterol [ Time Frame: 10 weeks ]
    plasma levels as mg/dL

  7. TG [ Time Frame: 10 weeks ]
    plasma levels as 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 triglyceride 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
  • regular use of anti-inflammatory medications
  • Above normal coagulation time or use of anticoagulant medications
  • allergy to fish, fish oil, or shellfish
  • uncontrolled thyroid dysfunction
  • insulin-dependent type 2 diabetes mellitus
  • kidney or liver disease
  • smoking
  • drinking more than 7 alcoholic drinks/week
  • use of lipid-lowering medications or medications known to alter lipoprotein metabolism

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): NCT02670356


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
Prevention Pharmaceuticals
Investigators
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Principal Investigator: Stefania Lamon-Fava, Ph.D. Tufts University
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Responsible Party: Stefania lamon-Fava, Scientist I. Associate Professor, Tufts University
ClinicalTrials.gov Identifier: NCT02670356    
Other Study ID Numbers: 11787
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stefania lamon-Fava, Tufts University:
fish oil
EPA
DHA
krill oil
Metabolic Syndrome
Additional relevant MeSH terms:
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Dyslipidemias
Inflammation
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases