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Completed

NCT Number: NCT01061554

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

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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Key information

Conditions

Age range

19 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nord-Trøndelag University College

Namsos, Nord-Trøndelag, N-7729, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 oils from tri-glycerides

Dietary Supplement

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

Omega-3 oils from marine phospholipids

Dietary Supplement

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Ayanda AS

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2010
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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