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Completed

NCT Number: NCT01214278

Bioavailability of Different n-3 Fatty Acid Formulations

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

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gottfried Wilhelm leibniz University of Hanover

Hanover, Lower Saxony, 30167, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTG

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)

Other names: re-esterified triglycerides

GArTG

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)

Other names: rTG in gastric acid resistant capsules

EE

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)

Other names: ethylesters

KPL

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)

Other names: phospholipids from krill-oil

Primary outcomes

  1. Area under concentration time curve (AUC)

    Time frame: 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 outcomes

  1. Area under concentration time curve (AUC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gottfried Wilhelm Leibniz Universität Hannover

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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