NCT01214278

Bioavailability of Different n-3 Fatty Acid Formulations

Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Gottfried Wilhelm Leibniz Universität Hannover · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health

Interventions

Type	Name	Description
DRUG	rTG	EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil; uncoated capsules (4 per day); 2016 mg n3 fatty acids daily (1008 mg EPA and 672 mg DHA)
DRUG	GArTG	EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG); 4 capsules per day; 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA)
DRUG	EE	EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules (4 per day); 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA)
DRUG	KPL	DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL); 7 capsules per day; 2100 mg n-3 fatty acids (1050 mg EPA and 630 mg DHA)

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-10-05
• Last updated: 2011-12-07

Locations

1 site across 1 country: Germany