Krill Oil Study Compared to Fish Oil

This study has been completed.

Sponsor:

Collaborator:

Enzymotec

Information provided by (Responsible Party):

Dr. Peter Jones, University of Manitoba

ClinicalTrials.gov Identifier:

NCT01323036

First received: March 23, 2011

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2011
Last Updated Date	November 21, 2012
Start Date ^ICMJE	May 2011
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 24, 2011)	Bioavailability [ Time Frame: 1 month ] [ Designated as safety issue: No ] 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	Complete list of historical versions of study NCT01323036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 Arm (s)	Experimental: Krill Oil N/A Intervention: Dietary Supplement: Krill oil Experimental: Fish Oil N/A Intervention: Dietary Supplement: Fish Oil
Publications *	Not Provided
* 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
Enrollment ^ICMJE	24
Completion Date	November 2012
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
Gender	Both
Ages	18 Years to 49 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01323036
Other Study ID Numbers ^ICMJE	B2011:014
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Peter Jones, University of Manitoba
Study Sponsor ^ICMJE	University of Manitoba
Collaborators ^ICMJE	Enzymotec
Investigators ^ICMJE	Not Provided
Information Provided By	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

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