Bioavailability of Fish Oils: Emulsified Versus Capsular... | NCT01488747

Studies
Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

NCT01488747

Sponsor

USDA Grand Forks Human Nutrition Research Center

Status

Completed

Last Update Posted

Aug 3, 2018Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

Coromega Omega-3 Squeeze
Coromega Nectar
Barleans Swirl
Nordic Omega-3 Softgel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Apr 2016Actual

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Dec 7, 2011

First Posted Date

Dec 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coromega Omega-3 Squeeze	Experimental	5.03 g	Dietary Supplement: Coromega Omega-3 Squeeze
Coromega Nectar	Experimental	12.22 g	Dietary Supplement: Coromega Nectar
Barleans Swirl	Experimental	17.45 g	Dietary Supplement: Barleans Swirl
Nordic Omega-3 Softgel	Active Comparator	4 softgels	Dietary Supplement: Nordic Omega-3 Softgel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coromega Omega-3 Squeeze	Dietary Supplement	660 mg EPA, 434 mg DHA	Coromega Omega-3 Squeeze

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve for phospholipid fatty acids	Evaluation of the bioavailability of fatty acids from fish oil supplements	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Area under the curve for chylomicron fatty acids	Evaluation of the bioavailability of fatty acids from fish oil supplements	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Raatz, PhD, RD	USDA Grand Forks Human Nutrition Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USDA Grand Forks Human Nutrition Research Center		Grand Forks	North Dakota	58203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19465191	Background	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. doi: 10.1016/j.jada.2009.03.006.