Bioavailability of Different n-3 Fatty Acid Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M. Sc. Simone Schmidt, Gottfried Wilhelm Leibniz Universität Hannover
ClinicalTrials.gov Identifier:
NCT01214278
First received: October 4, 2010
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Health
Drug: rTG
Drug: GArTG
Drug: EE
Drug: KPL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans

Resource links provided by NLM:


Further study details as provided by Gottfried Wilhelm Leibniz Universität Hannover:

Primary Outcome Measures:
  • Area under concentration time curve (AUC) [ Time Frame: about 24 hours ] [ Designated as safety issue: No ]
    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:
  • Area under concentration time curve (AUC) [ Time Frame: about 48 and 72 hours ] [ Designated as safety issue: No ]
    Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8, 24, 48 and 72 hours.


Enrollment: 12
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement 1
EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
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)
Other Name: re-esterified triglycerides
Experimental: Supplement 2
EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)
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)
Other Name: rTG in gastric acid resistant capsules
Experimental: Supplement 3
EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
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)
Other Name: ethylesters
Experimental: Supplement 4
DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)
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)
Other Name: phospholipids from krill-oil

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214278

Locations
Germany
Gottfried Wilhelm leibniz University of Hanover
Hanover, Lower Saxony, Germany, 30167
Sponsors and Collaborators
Gottfried Wilhelm Leibniz Universität Hannover
Investigators
Study Director: Andreas Hahn, Prof. Gottfried Wilhelm Leibniz University of Hanover
  More Information

Additional Information:
No publications provided

Responsible Party: M. Sc. Simone Schmidt, Master of Science, Gottfried Wilhelm Leibniz Universität Hannover
ClinicalTrials.gov Identifier: NCT01214278     History of Changes
Other Study ID Numbers: GWLUH-002, GWLUH2010
Study First Received: October 4, 2010
Last Updated: December 6, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Gottfried Wilhelm Leibniz Universität Hannover:
bioavailability
marine n-3 fatty acids
EPA
DHA

ClinicalTrials.gov processed this record on July 22, 2014