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

• ClinicalTrials.gov Identifier: NCT01960660
• Recruitment Status: Completed
• First Posted: October 10, 2013
• Last Update Posted: December 14, 2015
• Sponsor: Nordic Pharma, USA
• Collaborator: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Information provided by (Responsible Party): Nordic Pharma, USA

Tracking Information

• First Submitted Date: October 8, 2013
• First Posted Date: October 10, 2013
• Last Update Posted Date: December 14, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Comparative Bioavailability

Intervention

Dietary Supplement: Omega-3 Fatty Acids

Other Names:

• EPA: Eicosapentaenoic acid (20:5(n-3))
• DHA: Docosahexaenoic acid (22:6(n-3))

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 9, 2013): 35
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01960660
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Nordic Pharma, USA
• Study Sponsor: Nordic Pharma, USA
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Investigators

• 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