Bioavailability of Different n-3 Fatty Acid Formulations

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to examine differences in short term bioavailability between four n-3 FA formulations in healthy males.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gottfried Wilhelm Leibniz Universität Hannover

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