Healthy Adults Clinical Trial
Official title:
Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
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 |
Verified date | August 2018 |
Source | USDA Grand Forks Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | USDA Grand Forks Human Nutrition Research Center | Grand Forks | North Dakota |
Lead Sponsor | Collaborator |
---|---|
USDA Grand Forks Human Nutrition Research Center |
United States,
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
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 |
Status | Clinical Trial | Phase | |
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