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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
27
Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids
Nord-Trøndelag University College
Namsos, Nord-Trøndelag, Norway
The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA)
Time frame: 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)
Time frame: 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
Time frame: 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 EPA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)