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NCT01960660

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

NCT ID: NCT01960660

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Comparative Bioavailability

Keywords

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Fish Oil EPA DHA Omega-Score Lipemic Index ethyl esters triglycerides phospholipids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Investigational Product

Omega-3 fatty acids in the form of triglycerides

Group Type EXPERIMENTAL

Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Comparator Product 1

Omega-3 fatty acids in the form of ethyl esters.

Group Type ACTIVE_COMPARATOR

Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Comparator Product 2

Omega-3 fatty acids in the form of phospholipids from krill oil.

Group Type ACTIVE_COMPARATOR

Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Comparator Product 3

Omega-3 fatty acids from salmon oil.

Group Type ACTIVE_COMPARATOR

Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega-3 Fatty Acids

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role collaborator

Nordic Pharma, USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maggie D Laidlaw, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nutrasource Diagnostics

Carla Cockerline, M.Sc

Role: STUDY_DIRECTOR

Nutrasource Diagnostics

Locations

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Nutrasource Diagnostics Inc

Guelph, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 24952576 (View on PubMed)

Other Identifiers

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12-03-001

Identifier Type: OTHER

Identifier Source: secondary_id

12.0216

Identifier Type: -

Identifier Source: org_study_id