Clincosm LogoSign in Get a demo

Bioavailability of Different n-3 Fatty Acid Formulations

Sponsor
Gottfried Wilhelm Leibniz Universität Hannover (Other)
Overall Status
Completed
CT.gov ID
NCT01214278
Collaborator
(none)
12
Enrollment
1
Location
4
Arms
9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • phospholipids from krill-oil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under concentration time curve (AUC) [about 24 hours]

      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

    1. Area under concentration time curve (AUC) [about 48 and 72 hours]

      Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8, 24, 48 and 72 hours.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M. Sc. Simone Schmidt, Master of Science, Gottfried Wilhelm Leibniz Universität Hannover
    ClinicalTrials.gov Identifier:
    NCT01214278
    Other Study ID Numbers:
    • GWLUH-002
    • GWLUH2010
    First Posted:
    Oct 5, 2010
    Last Update Posted:
    Dec 7, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by M. Sc. Simone Schmidt, Master of Science, Gottfried Wilhelm Leibniz Universität Hannover
    bioavailability
    marine n-3 fatty acids
    EPA
    DHA

    Study Results

    No Results Posted as of Dec 7, 2011