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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric stable emulsion | Experimental | A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils |
|
| Soft gel capsule (TG) | Active Comparator | Soft gel capsule for administration of tri-glyceride based omega-3 oils |
|
| Soft gel capsules (MPL) | Active Comparator | Soft gel capsule for administration of marine phospholipids based omega-3 oils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 oils from tri-glycerides | Dietary Supplement | Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nord-Trøndelag University College | Namsos | Nord-Trøndelag | N-7729 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| Omega-3 oils from marine phospholipids | Dietary Supplement | Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids |
|
| 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) |
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