Bioavailability of Different n-3 Fatty Acid Formulations

Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214278
• Other study ID #: GWLUH-002
• Secondary ID: GWLUH2010
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2010
• Last updated: December 6, 2011
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: Gottfried Wilhelm Leibniz Universität Hannover
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health

Intervention

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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Gottfried Wilhelm leibniz University of Hanover	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Gottfried Wilhelm Leibniz Universität Hannover

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under concentration time curve (AUC)	Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8 and 24 hours.	about 24 hours	No
Secondary	Area under concentration time curve (AUC)	Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8, 24, 48 and 72 hours.	about 48 and 72 hours	No

External Links

•   web page of the institute