Status:
COMPLETED
Bioavailability of Different n-3 Fatty Acid Formulations
Lead Sponsor:
Gottfried Wilhelm Leibniz Universität Hannover
Conditions:
Health
Eligibility:
MALE
20-50 years
Phase:
PHASE4
Brief Summary
The aim of this study is to examine differences in short term bioavailability between four n-3 FA formulations in healthy males.
Detailed Description
The long-chain n-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are known to positively affect the lipid profile, vascular tone and blood coagulation. Moreover, EPA...
Eligibility Criteria
Inclusion
- males,
- 20-50 years,
- Caucasian,
- healthy,
- body mass index (BMI) 20-28 kg/m²,
- no medical treatment,
- written confirmation of the subjects after detailed spoken and written explanation about the study contents,
- ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the study drugs according to the dosage commendation
Exclusion
- medical treatment (especially corticosteroids, anti-inflammatory drugs, blood lipids lowering drugs (e.g. statines, fibrates, bile acid exchanger resin, phytosterols)
- taking any supplements with n-3 FAs, phytosterols, polyglucosamines (Chitosan) or other lipid binding ingredients
- daily consumption of n-3 FAs rich fish (salmon, mackerel, herring)
- heavy chronic diseases (tumors, diabetes typ 1, etc.), documented heart disease, documented blood clotting disorders, renal failure, liver diseases
- documented blood clotting disorders and consumption of coagulation-inhibiting drugs (for example Marcumar, ASS)
- allergy or intolerance to fish/fish oil or any of the study ingredients of the test products
- chronic gastro-intestinal diseases (Colitis ulcerosa, Morbus Crohn, pancreatic insufficiency)
- donation of blood in the last 6 weeks
- routine consumption of laxative
- alcohol-, drug- and/or medicament dependence
- subjects who are not in agreement with the study conditions
- refusal or rather reset of the consent from the subject
- active participation in other investigational drug or device trial within the last 30 days
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01214278
Start Date
October 1 2010
End Date
July 1 2011
Last Update
December 7 2011
Active Locations (1)
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1
Gottfried Wilhelm leibniz University of Hanover
Hanover, Lower Saxony, Germany, 30167