Bioavailability of Different n-3 Fatty Acid Formulations

NCT ID: NCT01214278

Last Updated: 2011-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Health

Keywords

bioavailability; marine n-3 fatty acids; EPA; DHA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Supplement 1

EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules

Group Type: EXPERIMENTAL

rTG

Intervention Type: DRUG

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)

Supplement 2

EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)

Group Type: EXPERIMENTAL

GArTG

Intervention Type: DRUG

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)

Supplement 3

EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules

Group Type: EXPERIMENTAL

EE

Intervention Type: DRUG

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)

Supplement 4

DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)

Group Type: EXPERIMENTAL

KPL

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

re-esterified triglycerides; rTG in gastric acid resistant capsules; ethylesters; phospholipids from krill-oil

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gottfried Wilhelm Leibniz Universität Hannover

OTHER

Sponsor Role: lead

Responsible Party

M. Sc. Simone Schmidt

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Hahn, Prof.

Role: STUDY_DIRECTOR

Gottfried Wilhelm Leibniz University of Hanover

Locations

Gottfried Wilhelm leibniz University of Hanover

Hanover, Lower Saxony, Germany

Countries

Germany

Related Links

http://www.nutrition.uni-hannover.de

web page of the institute

Other Identifiers

GWLUH2010

Identifier Type: OTHER

Identifier Source: secondary_id

GWLUH-002

Identifier Type: -

Identifier Source: org_study_id