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

This study has been completed.
Sponsor:
Information provided by:
Ayanda AS
ClinicalTrials.gov Identifier:
NCT01061554
First received: February 2, 2010
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
 Dietary Supplement: Omega-3 oils from tri-glycerides
Dietary Supplement: Omega-3 oils from marine phospholipids
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

Further study details as provided by Ayanda AS:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastric stable emulsion
A gastric stable emulsion vehicle for administration of tri-glyceride based omega-3 oils
 Dietary Supplement: Omega-3 oils from tri-glycerides
Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
Active Comparator: Soft gel capsule (TG)
Soft gel capsule for administration of tri-glyceride based omega-3 oils
 Dietary Supplement: Omega-3 oils from tri-glycerides
Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides
Active Comparator: Soft gel capsules (MPL)
Soft gel capsule for administration of marine phospholipids based omega-3 oils
 Dietary Supplement: Omega-3 oils from marine phospholipids
Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids

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.

  Eligibility

Ages Eligible for Study:   19 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061554

Locations
Norway
Nord-Trøndelag University College
Namsos, Nord-Trøndelag, Norway, N-7729
Sponsors and Collaborators
Ayanda AS
  More Information

Additional Information:
EMEA. (2001). CPMP/EWP/QWP/1401/98 - Note for Guidance on the investigation of bioavailability and bioequivalence, The European Agency for the Evaluation of Medicinal Products, London  This link exits the ClinicalTrials.gov site

Publications:
Hsu, J. C. (1992). The Factor Analytic Approach to Simultaneous Inference in the General Linear Model. Journal of Computational and Graphical Statistics, 1(2), 151-168.

Responsible Party: Tore Seternes, Ayanda AS
ClinicalTrials.gov Identifier: NCT01061554     History of Changes
Other Study ID Numbers: AYANDA-CC-01
Study First Received: February 2, 2010
Last Updated: February 2, 2010
Health Authority: Norway: Ethics Committee

Keywords provided by Ayanda AS:
Bioavailability
Eicosapentaenoic acid
Docosahexaenoic acid
Soft gel capsules
 Gastric stable emulsion
Omega-3
Tri-glycerides
Marine phospholipids

ClinicalTrials.gov processed this record on May 22, 2013