Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Brian G Dyson Foundation

Information provided by (Responsible Party):

Susan Raatz, USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT01488747

First received: December 6, 2011

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 6, 2011
Last Updated Date	February 27, 2013
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2011)	Area under the curve for phospholipid fatty acids [ Time Frame: 48 hours ] [ Designated as safety issue: No ] Evaluation of the bioavailability of fatty acids from fish oil supplements
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01488747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2011)	Area under the curve for chylomicron fatty acids [ Time Frame: 48 hours ] [ Designated as safety issue: No ] Evaluation of the bioavailability of fatty acids from fish oil supplements
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride
Official Title ^ICMJE	Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
Brief Summary	The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools. The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Healthy Adults
Intervention ^ICMJE	Dietary Supplement: Coromega Omega-3 Squeeze 660 mg EPA, 434 mg DHA Dietary Supplement: Coromega Nectar 660 mg EPA, 436 mg DHA Dietary Supplement: Barlean Swirl 660 mg EPA, 660 mg DHA Dietary Supplement: Nordic Omega-3 Softgel 660 mg EPA, 440 mg DHA
Study Arm (s)	Experimental: Coromega Omega-3 Squeeze 5.03 g Intervention: Dietary Supplement: Coromega Omega-3 Squeeze Experimental: Coromega Nectar 12.22 g Intervention: Dietary Supplement: Coromega Nectar Experimental: Barleans Swirl 17.45 g Intervention: Dietary Supplement: Barlean Swirl Active Comparator: Nordic Omega-3 Softgel 4 softgels Intervention: Dietary Supplement: Nordic Omega-3 Softgel
Publications *	Raatz SK, Redmon JB, Wimmergren N, Donadio JV, Bibus DM. Enhanced absorption of n-3 fatty acids from emulsified compared with encapsulated fish oil. J Am Diet Assoc. 2009 Jun;109(6):1076-81.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	November 2013
Estimated Primary Completion Date	November 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy adults ages 18 to 60. Body mass index between 22 and 32 kg/m2. Medical history (interview) demonstrating good health. Nonsmoker. Consumption of a typical American diet with no unusual dietary habits. Willingness to comply with the study protocol. Low reported n-3 intake (<100 mg/d) on the Omega-3 Checklist Exclusion Criteria: Any active, uncontrolled medical problem. Consumption of essential fatty acid supplements within the past 6 months. Use of lipid lowering drugs. Fish consumption greater than 1 fish meal per week
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01488747
Other Study ID Numbers ^ICMJE	GFHNRC023
Has Data Monitoring Committee	Yes
Responsible Party	Susan Raatz, USDA Grand Forks Human Nutrition Research Center
Study Sponsor ^ICMJE	USDA Grand Forks Human Nutrition Research Center
Collaborators ^ICMJE	Brian G Dyson Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	USDA Grand Forks Human Nutrition Research Center
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top