Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride
1 other identifier
interventional
19
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 3, 2018
August 1, 2018
11 months
December 6, 2011
August 1, 2018
Conditions
Keywords
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
EXPERIMENTAL5.03 g
Coromega Nectar
EXPERIMENTAL12.22 g
Barleans Swirl
EXPERIMENTAL17.45 g
Nordic Omega-3 Softgel
ACTIVE COMPARATOR4 softgels
Interventions
Eligibility Criteria
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
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
- PRINCIPAL INVESTIGATOR
Susan Raatz, PhD, RD
USDA Grand Forks Human Nutrition Research Center
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