Health
Conditions
Keywords
bioavailability, marine n-3 fatty acids, EPA, DHA
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.
Interventions
DRUGrTG
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)
DRUGGArTG
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)
DRUGEE
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)
DRUGKPL
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)
Sponsors
Gottfried Wilhelm Leibniz Universität Hannover
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed