Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061554

Enrollment

Registered

2010-02-03

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Soft gel capsules, Gastric stable emulsion, Omega-3, Tri-glycerides, Marine phospholipids

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 oils from tri-glycerides

Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides

DIETARY_SUPPLEMENTOmega-3 oils from marine phospholipids

Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 29 Years

Healthy volunteers

Yes

Inclusion criteria

* Student at Nord-Trondelag University College * Healthy (no known condition) * Males and females aged 19 to 29 years

Exclusion criteria

* Fish allergies * Ongoing consumption of omega-3 fatty acids * Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment * Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity

Design outcomes

Primary

Measure	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)

Secondary

Measure	Time frame
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 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 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)
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 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)
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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026