Nord-Trøndelag University College
Namsos, Nord-Trøndelag, N-7729, Norway
NCT Number: NCT01061554
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.
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Notify Me19 year–29 year
All sexes
Interventional
Phase 1
Namsos, Nord-Trøndelag, N-7729, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Time frame: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
Ayanda AS
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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