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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01488747
Other study ID # GFHNRC023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date April 2016

Study information

Verified date August 2018
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date April 2016
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coromega Omega-3 Squeeze
660 mg EPA, 434 mg DHA
Coromega Nectar
660 mg EPA, 436 mg DHA
Barleans Swirl
660 mg EPA, 660 mg DHA
Nordic Omega-3 Softgel
660 mg EPA, 440 mg DHA

Locations

Country Name City State
United States USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (1)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the curve for phospholipid fatty acids Evaluation of the bioavailability of fatty acids from fish oil supplements 48 hours
Secondary Area under the curve for chylomicron fatty acids Evaluation of the bioavailability of fatty acids from fish oil supplements 48 hours
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