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

Study Overview
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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.

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

Conditions
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Comparative Bioavailability

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product<br>Omega-3 fatty acids in the form of triglycerides | Dietary Supplement: Omega-3 Fatty Acids<br> <br> * Other names: DHA: Docosahexaenoic acid (22:6(n-3));|
| Active Comparator: Comparator Product 1<br>Omega-3 fatty acids in the form of ethyl esters. | Dietary Supplement: Omega-3 Fatty Acids<br> <br> * Other names: DHA: Docosahexaenoic acid (22:6(n-3));|
| Active Comparator: Comparator Product 2<br>Omega-3 fatty acids in the form of phospholipids from krill oil. | Dietary Supplement: Omega-3 Fatty Acids<br> <br> * Other names: DHA: Docosahexaenoic acid (22:6(n-3));|
| Active Comparator: Comparator Product 3<br>Omega-3 fatty acids from salmon oil. | Dietary Supplement: Omega-3 Fatty Acids<br> <br> * Other names: DHA: Docosahexaenoic acid (22:6(n-3));|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-Score | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish Oil, EPA, DHA, Omega-Score, Lipemic Index, ethyl esters, triglycerides, phospholipids