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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
  Purpose

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.


Condition Intervention
Healthy Adults
 Dietary Supplement: Coromega Omega-3 Squeeze
Dietary Supplement: Coromega Nectar
Dietary Supplement: Barlean Swirl
Dietary Supplement: Nordic Omega-3 Softgel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Barlean 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488747

Locations
United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Brian G Dyson Foundation
  More Information

Additional Information:
USDA Grand Forks Human Nutrition Research Center  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Susan Raatz, PhD, RD, Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01488747     History of Changes
Other Study ID Numbers: GFHNRC023
Study First Received: December 6, 2011
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Omega-3 fatty acids
Phospholipid fatty acids
chymlomicron fatty acids
Bioavailability fo fish oil supplements in healthy adults

ClinicalTrials.gov processed this record on May 23, 2013