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Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

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ClinicalTrials.gov Identifier: NCT01488747
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Healthy Adults Dietary Supplement: Coromega Omega-3 Squeeze Dietary Supplement: Coromega Nectar Dietary Supplement: Barleans Swirl Dietary Supplement: Nordic Omega-3 Softgel

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
Study Start Date : November 2011
Primary Completion Date : October 2012
Study Completion Date : April 2016
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Area under the curve for phospholipid fatty acids [ Time Frame: 48 hours ]
    Evaluation of the bioavailability of fatty acids from fish oil supplements


Secondary Outcome Measures :
  1. Area under the curve for chylomicron fatty acids [ Time Frame: 48 hours ]
    Evaluation of the bioavailability of fatty acids from fish oil supplements


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Susan Raatz, PhD, RD USDA Grand Forks Human Nutrition Research Center
More Information

Additional Information:
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
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Susan Raatz, 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