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

December 10, 2015 updated by: Nordic Pharma, USA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G0B4
        • Nutrasource Diagnostics Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline in Omega-Score at 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline in Lipemic Index at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12.0216
  • 12-03-001 (OTHER: Canadian SHIELD Ethics Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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