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OpenTrials
Completed

NCT Number: NCT01960660

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

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.

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Key information

Conditions

Comparative Bioavailability Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrasource Diagnostics Inc

Guelph, Ontario, N1G0B4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nordic Pharma, USA

Industry

Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 10, 2013
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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