Clinical trial NCT01214278: Bioavailability of Different n-3 Fatty Acid Formulations
Official title: Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Health
Keywords: bioavailability
marine n-3 fatty acids
EPA
DHA
Lead sponsor: Gottfried Wilhelm Leibniz Universität Hannover
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 and DHA possess anti-inflammatory effects and play a central role in the functioning of the brain and central nervous system. Therefore, an increased EPA and DHA intake is highly recommend. However, it is unknown whether different chemical formulations of EPA + DHA rich supplements (re-esterified triglycerides, ethyl-esters, phospholipids) have identical bioavailability. The objective of this study is to examine differences in short term bioavailability between four n-3 FA formulations:

* Supplement 1: EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
* Supplement 2: EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)
* Supplement 3: EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
* Supplement 4: DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)

The study preparations are certificated supplements and available on the market.

There are no comparative investigations, which analyzed the bioavailability of these four n-3 FA formulations in a similar design.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Area under concentration time curve (AUC)
timeFrame: about 24 hours
Secondary outcomes:
measure: Area under concentration time curve (AUC)
timeFrame: about 48 and 72 hours
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Gottfried Wilhelm leibniz University of Hanover
state: Lower Saxony
Study officials:
affiliation: Gottfried Wilhelm Leibniz University of Hanover
name: Andreas Hahn, Prof.
role: STUDY_DIRECTOR
References: