Bioavailability of Different n-3 Fatty Acid Formulations

Phase 4

Completed

• Conditions: Health
• Interventions: Drug: GArTG; Drug: EE; Drug: KPL; Drug: rTG

• Registration Number: NCT01214278
• Lead Sponsor: Gottfried Wilhelm Leibniz Universität Hannover

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-06
• Last Update Posted: 2011-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area under concentration time curve (AUC)	about 24 hours	Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8 and 24 hours.

Secondary Outcome Measures

Name	Time	Method
Area under concentration time curve (AUC)	about 48 and 72 hours	Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8, 24, 48 and 72 hours.

Trial Locations

Locations (1)

Gottfried Wilhelm leibniz University of Hanover; 🇩🇪 Hanover, Lower Saxony, Germany