Bioavailability of Different n-3 Fatty Acid Formulations

Gottfried Wilhelm Leibniz Universität Hannover

Status and phase: Completed; Phase 4

Conditions: Health

Treatments: Drug: rTG; Drug: EE; Drug: KPL; Drug: GArTG

Study type: Interventional

Funder types: Other

Identifiers

NCT01214278

GWLUH-002

GWLUH2010 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 4 patient groups

Supplement 1

Experimental group

Description:

EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules

Treatment:

Drug: rTG

Supplement 2

Experimental group

Description:

EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)

Treatment:

Drug: GArTG

Supplement 3

Experimental group

Description:

EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules

Treatment:

Drug: EE

Supplement 4

Experimental group

Description:

DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)

Treatment:

Drug: KPL