A Phase 1 interventional study of Omega-3 oils from tri-glycerides and Omega-3 oils from marine phospholipids in Healthy, sponsored by Ayanda AS. Completed at 1 site in Norway. Open to participants aged 19 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-03.
Sponsored by Ayanda AS · Phase 1, Interventional, and Basic science
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.
This is the only study on the registry with Ayanda AS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils
Dietary Supplement: Omega-3 oils from tri-glycerides
Soft gel capsule for administration of tri-glyceride based omega-3 oils
Dietary Supplement: Omega-3 oils from tri-glycerides
Soft gel capsule for administration of marine phospholipids based omega-3 oils
Dietary Supplement: Omega-3 oils from marine phospholipids
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
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
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)
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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