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Krill Oil Study Compared to Fish Oil (Krill)

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: NCT01323036
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : November 22, 2012
Sponsor:
Collaborator:
Enzymotec
Information provided by (Responsible Party):
Dr. Peter Jones, University of Manitoba

Study Description
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Brief Summary:
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Krill oil Dietary Supplement: Fish Oil Not Applicable

Detailed Description:
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Krill Oil Dietary Supplement: Krill oil
Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
Experimental: Fish Oil Dietary Supplement: Fish Oil
Fish oil: Total omega-3 fatty acids: 560-660 mg


Outcome Measures
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Primary Outcome Measures :
  1. Bioavailability [ Time Frame: 1 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.

Exclusion Criteria:

  • smokers
  • rheumatoid arthritis
  • chronic illness
  • cardiovascular problems
  • dyslipidemia
  • liver and kidney disease
  • diabetes
  • endocrine or metabolic disease
  • inflammatory bowel disease
  • pancreatitis
  • gallbladder or biliary disease
  • neurological/psychological disease
  • bleeding disorders
  • experienced platelet abnormalities
  • gastrointestinal disorders that could interfere with fat absorption
  • hypertension
  • history of cancer
  • an intention to lose weight
  • use of anticoagulant
  • serum triglycerides (TG) >200 mg/dL, and/or total cholesterol (TC) >240 mg/dL, and/or LDL-cholesterol (LDL-C) >160 mg/dL
  • hypertension or lipid lowering medications
  • consumption of more than one alcoholic drinks/day
  • Consumption of more than one fish or seafood serving
  • one month prior to the start of the study
  • omega-6 fatty acids in the past 6 months
  • planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
  • planned to to become pregnant during the study period
  • BMI>28
  • allergies to fish seafood or corn
Contacts and Locations
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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): NCT01323036


Locations
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Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Enzymotec
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Peter Jones, Director of RCFFN, University of Manitoba
ClinicalTrials.gov Identifier: NCT01323036    
Other Study ID Numbers: B2011:014
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012