Bioavailability of Different n-3 Fatty Acid Formulations

NCT01214278 | Completed Phase 4

• 2 other identifiers: GWLUH-002GWLUH2010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health

Keywords

bioavailability; marine n-3 fatty acids; EPA; DHA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area under concentration time curve (AUC)

  about 48 and 72 hours

Study Arms (4)

Supplement 1

EXPERIMENTAL

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

Drug: rTG

Supplement 2

EXPERIMENTAL

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

Drug: GArTG

Supplement 3

EXPERIMENTAL

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

Drug: EE

Supplement 4

EXPERIMENTAL

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

Drug: KPL

Interventions

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)

Also known as: re-esterified triglycerides

Supplement 1

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)

Also known as: rTG in gastric acid resistant capsules

Supplement 2

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)

Also known as: ethylesters

Supplement 3

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)

Also known as: phospholipids from krill-oil

Supplement 4

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gottfried Wilhelm Leibniz Universität Hannover: lead

Study Sites (1)

Gottfried Wilhelm leibniz University of Hanover

Hanover, Lower Saxony, 30167, Germany

Location

Related Links

• web page of the institute

MeSH Terms

Interventions

ezogabine

Study Officials

• Andreas Hahn, Prof.

  Gottfried Wilhelm Leibniz University of Hanover

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

DE (1)