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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

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 25, 2011
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
Bioavailability [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
Bioavailability [ Time Frame: 1 month ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Krill Oil Study Compared to Fish Oil
Official Title  ICMJE Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Dietary Supplement: Krill oil
    Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
  • Dietary Supplement: Fish Oil
    Fish oil: Total omega-3 fatty acids: 560-660 mg
Study Arms  ICMJE
  • Experimental: Krill Oil
    Intervention: Dietary Supplement: Krill oil
  • Experimental: Fish Oil
    Intervention: Dietary Supplement: Fish Oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2011)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01323036
Other Study ID Numbers  ICMJE B2011:014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Peter Jones, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Enzymotec
Investigators  ICMJE Not Provided
PRS Account University of Manitoba
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP