Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 23, 2011
November 21, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
Bioavailability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01323036 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Krill Oil Study Compared to Fish Oil
Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • 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
  • Experimental: Krill Oil
    N/A
    Intervention: Dietary Supplement: Krill oil
  • Experimental: Fish Oil
    N/A
    Intervention: Dietary Supplement: Fish Oil
Ramprasath VR, Eyal I, Zchut S, Jones PJ. Enhanced increase of omega-3 index in healthy individuals with response to 4-week n-3 fatty acid supplementation from krill oil versus fish oil. Lipids Health Dis. 2013 Dec 5;12:178. doi: 10.1186/1476-511X-12-178.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01323036
B2011:014
Yes
Dr. Peter Jones, University of Manitoba
University of Manitoba
Enzymotec
Not Provided
University of Manitoba
November 2012

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