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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 Pharmaceutical and Nutraceutical Services, Inc.
Information provided by (Responsible Party):
Nordic Pharma, USA

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Official Title  ICMJE A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Comparative Bioavailability
Intervention  ICMJE Dietary Supplement: Omega-3 Fatty Acids
Other Names:
  • EPA: Eicosapentaenoic acid (20:5(n-3))
  • DHA: Docosahexaenoic acid (22:6(n-3))
Study Arms  ICMJE
  • Experimental: Investigational Product
    Omega-3 fatty acids in the form of triglycerides
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Active Comparator: Comparator Product 1
    Omega-3 fatty acids in the form of ethyl esters.
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Active Comparator: Comparator Product 2
    Omega-3 fatty acids in the form of phospholipids from krill oil.
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Active Comparator: Comparator Product 3
    Omega-3 fatty acids from salmon oil.
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
Publications * Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99.

*   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: October 9, 2013)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT01960660
Other Study ID Numbers  ICMJE 12.0216
12-03-001 ( Other Identifier: Canadian SHIELD Ethics Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nordic Pharma, USA
Study Sponsor  ICMJE Nordic Pharma, USA
Collaborators  ICMJE Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Investigators  ICMJE
Principal Investigator: Maggie D Laidlaw, Ph.D Nutrasource Diagnostics
Study Director: Carla Cockerline, M.Sc Nutrasource Diagnostics
PRS Account Nordic Pharma, USA
Verification Date December 2015

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