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A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products

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: NCT01960660
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Nutrasource Diagnostics Inc.
Information provided by (Responsible Party):
Nordic Pharma, USA

Brief Summary:

Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.

The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.


Condition or disease Intervention/treatment Phase
Comparative Bioavailability Dietary Supplement: Omega-3 Fatty Acids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational Product
Omega-3 fatty acids in the form of triglycerides
Dietary Supplement: Omega-3 Fatty Acids
Other Names:
  • EPA: Eicosapentaenoic acid (20:5(n-3))
  • DHA: Docosahexaenoic acid (22:6(n-3))

Active Comparator: Comparator Product 1
Omega-3 fatty acids in the form of ethyl esters.
Dietary Supplement: Omega-3 Fatty Acids
Other Names:
  • EPA: Eicosapentaenoic acid (20:5(n-3))
  • DHA: Docosahexaenoic acid (22:6(n-3))

Active Comparator: Comparator Product 2
Omega-3 fatty acids in the form of phospholipids from krill oil.
Dietary Supplement: Omega-3 Fatty Acids
Other Names:
  • EPA: Eicosapentaenoic acid (20:5(n-3))
  • DHA: Docosahexaenoic acid (22:6(n-3))

Active Comparator: Comparator Product 3
Omega-3 fatty acids from salmon oil.
Dietary Supplement: Omega-3 Fatty Acids
Other Names:
  • EPA: Eicosapentaenoic acid (20:5(n-3))
  • DHA: Docosahexaenoic acid (22:6(n-3))




Primary Outcome Measures :
  1. Omega-Score [ Time Frame: Change from Baseline in Omega-Score at 28 days ]
    The Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.


Secondary Outcome Measures :
  1. Lipemic IndexTM [ Time Frame: Change from Baseline in Lipemic Index at 28 days ]
    The Lipemic Index™ is the post-prandial rise in TG levels over a 5-hour period, following the consumption drink containing a measured amount of fat, carbohydrate and protein.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is fluent in English
  • Participant understands the study requirements and is willing to comply with the protocol
  • Participant is willing to provide written informed consent
  • Participant is 18 years of age or older

Exclusion Criteria:

  • Unwilling or unable to provide written consent
  • Participant has taken omega-3 supplements in the last 3 months
  • Participants consumes fish on a regular basis (more than 1 serving per week)
  • Females who are pregnant or breastfeeding
  • Participant has an allergy to fish or seafood
  • Participant has been diagnosed with any medical illness or conditions
  • Participant has a history of drug dependence or substance abuse (excluding nicotine)
  • Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)
  • Individual has difficulty giving multiple blood samples

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): NCT01960660


Locations
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Canada, Ontario
Nutrasource Diagnostics Inc
Guelph, Ontario, Canada, N1G0B4
Sponsors and Collaborators
Nordic Pharma, USA
Nutrasource Diagnostics Inc.
Investigators
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Principal Investigator: Maggie D Laidlaw, Ph.D Nutrasource Diagnostics
Study Director: Carla Cockerline, M.Sc Nutrasource Diagnostics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordic Pharma, USA
ClinicalTrials.gov Identifier: NCT01960660    
Other Study ID Numbers: 12.0216
12-03-001 ( Other Identifier: Canadian SHIELD Ethics Review Board )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Nordic Pharma, USA:
Fish Oil
EPA
DHA
Omega-Score
Lipemic Index
ethyl esters
triglycerides
phospholipids