- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214278
Bioavailability of Different n-3 Fatty Acid Formulations
Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Lower Saxony
-
Hanover, Lower Saxony, Germany, 30167
- Gottfried Wilhelm Leibniz University of Hanover
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supplement 1
EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
|
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:
|
Experimental: Supplement 2
EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (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:
|
Experimental: Supplement 3
EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
|
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:
|
Experimental: Supplement 4
DHA+EPA as phospholipids from krill-oil, uncoated capsules (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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
about 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
about 48 and 72 hours
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GWLUH-002
- GWLUH2010 (OTHER: 01)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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