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

NCT ID: NCT01061554

Last Updated: 2010-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gastric stable emulsion

A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils

Group Type EXPERIMENTAL

Omega-3 oils from tri-glycerides

Intervention Type DIETARY_SUPPLEMENT

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

Soft gel capsule (TG)

Soft gel capsule for administration of tri-glyceride based omega-3 oils

Group Type ACTIVE_COMPARATOR

Omega-3 oils from tri-glycerides

Intervention Type DIETARY_SUPPLEMENT

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

Soft gel capsules (MPL)

Soft gel capsule for administration of marine phospholipids based omega-3 oils

Group Type ACTIVE_COMPARATOR

Omega-3 oils from marine phospholipids

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega-3 oils from tri-glycerides

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

Intervention Type DIETARY_SUPPLEMENT

Omega-3 oils from marine phospholipids

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ayanda AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Ayanda AS

Locations

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Nord-Trøndelag University College

Namsos, Nord-Trøndelag, Norway

Site Status

Countries

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Norway

References

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Other Identifiers

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AYANDA-CC-01

Identifier Type: -

Identifier Source: org_study_id

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