Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion

Study Overview
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Brief Summary
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The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.

Detailed Description
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The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE). In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.

Official Title
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Correlation Between Level of Polyunsaturated Fatty Acid EPA and DHA in Blood After Digestion of ProBios Omega-3 Concordix™ Compared With Omega-3 Soft Capsules - a Pilot

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Omega-3 oils from tri-glycerides
* Dietary Supplement: Omega-3 oils from marine phospholipids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Student at Nord-Trondelag University College Healthy (no known condition) Males and females aged 19 to 29 years Exclusion Criteria: Fish allergies Ongoing consumption of omega-3 fatty acids Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 29 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric stable emulsion<br>A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils | Dietary Supplement: Omega-3 oils from tri-glycerides<br>* Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides<br>|
| Active Comparator: Soft gel capsule (TG)<br>Soft gel capsule for administration of tri-glyceride based omega-3 oils | Dietary Supplement: Omega-3 oils from tri-glycerides<br>* Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides<br>|
| Active Comparator: Soft gel capsules (MPL)<br>Soft gel capsule for administration of marine phospholipids based omega-3 oils | Dietary Supplement: Omega-3 oils from marine phospholipids<br>* Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA) |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The incremental (change from baseline) area under the blood plasma concentration curve of docosahexaenoic acid (DHA) |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The incremental (change from baseline) area under the blood plasma concentration curve of Vitamin E |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximal incremental blood plasma concentration of EPA |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The maximal incremental blood plasma concentration of DHA |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The maximal incremental blood plasma concentration of Vitamin E |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The time passed since administration at which the incremental plasma concentration maximum occurs for EPA |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The time passed since administration at which the incremental plasma concentration maximum occurs for DHA |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 
| The time passed since administration at which the incremental plasma concentration maximum occurs for Vitamin E |  | 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Soft gel capsules, Gastric stable emulsion, Omega-3, Tri-glycerides, Marine phospholipids