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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Omega-3 oils from tri-glycerides; Dietary Supplement: Omega-3 oils from marine phospholipids

• Registration Number: NCT01061554
• Lead Sponsor: Ayanda AS

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.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Last Update Submitted: 2010-02-02
• Study First Posted: 2010-02-03
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric stable emulsion	Omega-3 oils from tri-glycerides	A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils
Soft gel capsule (TG)	Omega-3 oils from tri-glycerides	Soft gel capsule for administration of tri-glyceride based omega-3 oils
Soft gel capsules (MPL)	Omega-3 oils from marine phospholipids	Soft gel capsule for administration of marine phospholipids based omega-3 oils

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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 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)
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 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 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)

Trial Locations

Locations (1)

Nord-Trøndelag University College; 🇳🇴 Namsos, Nord-Trøndelag, Norway