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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061554
• Other study ID #: AYANDA-CC-01
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2010
• Last updated: February 2, 2010
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: April 2009
• Source: Ayanda AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 29 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Omega-3 oils from tri-glycerides
Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
• Omega-3 oils from marine phospholipids
Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids

Locations

Country	Name	City	State
Norway	Nord-Trøndelag University College	Namsos	Nord-Trøndelag

Sponsors (1)

Lead Sponsor	Collaborator
Ayanda AS

Country where clinical trial is conducted

Norway, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No