Healthy Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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