Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

August 1, 2018 updated by: USDA Grand Forks Human Nutrition Research Center

Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adults ages 18 to 60.
  2. Body mass index between 22 and 32 kg/m2.
  3. Medical history (interview) demonstrating good health.
  4. Nonsmoker.
  5. Consumption of a typical American diet with no unusual dietary habits.
  6. Willingness to comply with the study protocol.
  7. Low reported n-3 intake (<100 mg/d) on the Omega-3 Checklist

Exclusion Criteria:

  1. Any active, uncontrolled medical problem.
  2. Consumption of essential fatty acid supplements within the past 6 months.
  3. Use of lipid lowering drugs.
  4. Fish consumption greater than 1 fish meal per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coromega Omega-3 Squeeze
5.03 g
Dietary supplement: Coromega Omega-3 Squeeze
660 mg EPA, 434 mg DHA
Experimental: Coromega Nectar
12.22 g
Dietary supplement: Coromega Nectar
660 mg EPA, 436 mg DHA
Experimental: Barleans Swirl
17.45 g
Dietary supplement: Barleans Swirl
660 mg EPA, 660 mg DHA
Active Comparator: Nordic Omega-3 Softgel
4 softgels
Dietary supplement: Nordic Omega-3 Softgel
660 mg EPA, 440 mg DHA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Susan Raatz, PhD, RD, USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GFHNRC023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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