NCT01488747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

December 6, 2011

Last Update Submit

August 1, 2018

Conditions

Keywords

Omega-3 fatty acidsPhospholipid fatty acidschymlomicron fatty acidsBioavailability fo fish oil supplements in healthy adults

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for phospholipid fatty acids

    Evaluation of the bioavailability of fatty acids from fish oil supplements

    48 hours

Secondary Outcomes (1)

  • Area under the curve for chylomicron fatty acids

    48 hours

Study Arms (4)

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

Coromega Omega-3 SqueezeDIETARY_SUPPLEMENT

660 mg EPA, 434 mg DHA

Coromega Omega-3 Squeeze
Coromega NectarDIETARY_SUPPLEMENT

660 mg EPA, 436 mg DHA

Coromega Nectar
Barleans SwirlDIETARY_SUPPLEMENT

660 mg EPA, 660 mg DHA

Barleans Swirl
Nordic Omega-3 SoftgelDIETARY_SUPPLEMENT

660 mg EPA, 440 mg DHA

Nordic Omega-3 Softgel

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Publications (1)

  • 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.

    PMID: 19465191BACKGROUND

Related Links

Study Officials

  • Susan Raatz, PhD, RD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 8, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2012

Study Completion

April 1, 2016

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations