Modulation of Cytochrome-P450 dependent eicosanoid formation by treatment with omega-3 PUFA (Omacor®) - OMEICOS

• Conditions: Healthy volunteersintended indication of the product: primary and secondary prevention of cardiovascular morbidity and mortality

• Registration Number: EUCTR2009-013458-33-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- age 18-60 years
- male and female
- no known history of chronic diseases
- effective contraception in women- of childbearing age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- BMI >30 kg/m2
- intolerance to study medication (OMACOR) or its ingredients (soya bean oil, peanuts)
- aterial blood pressure >150/90 mm Hg
- consumption og marine fish > 1 meal/week or Omega-3-Index > 6
- regular intake of other diet supplements, which have an influence on metabolism of PUFA (e.g. vitamin E)
- regular intake of other medication (except for contraceptives, thyroid hormones)
- pregnancy and lactation period
- inherited lipometabolic disorders
- coagulation disorders and intake of anticoagulants

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Change in ratio of omega-3/omega-6 derived cytochrome-P450-dependent epoxyeicosanoids in erythrocytes by treatment with 1g and 2g of purified omega-3 PUFA (Omacor);Secondary Objective: - absolute and relative change in fatty acid profile in erythrocytes and urin<br>- change in heart rate variability<br>- change in inflammory markers;Primary end point(s): change in ratio of Omega-3/Omega-6 PUFA derived epoxyeicosanoids in erythocytes