Bioavailability of Different n-3 Fatty Acid Formulations

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

Detailed Description
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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.

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

Conditions
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Health

Intervention / Treatment
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* Drug: rTG
* Drug: GArTG
* Drug: EE
* Drug: KPL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement 1<br>EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules | Drug: rTG<br>* 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)<br>* Other names: re-esterified triglycerides;|
| Experimental: Supplement 2<br>EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG) | Drug: GArTG<br>* 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)<br>* Other names: rTG in gastric acid resistant capsules;|
| Experimental: Supplement 3<br>EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules | Drug: EE<br>* 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)<br>* Other names: ethylesters;|
| Experimental: Supplement 4<br>DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL) | Drug: KPL<br>* 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)<br>* Other names: phospholipids from krill-oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability, marine n-3 fatty acids, EPA, DHA