A placebo-controlled, randomized, single-centre, two-way crossover study to assess choline levels in plasma after a single dose of Superba Boost or choline bitartrate in healthy volunteers
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00015828
- Lead Sponsor
- Aker BioMarine Antarctic AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
• Healthy males or females (1:1) aged 18 - 65 years
• Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
• BMI =18 and =30 kg/m²
• Nonsmoker
Main exclusion criteria
• Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (colitis ulcerosa, Crohn’s IBS, peptic ulcers, celiac disease), heavy depression, diabetes, heavy liver disease, immunodeficiency, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
• A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
• Regular intake of drugs or supplements possibly interfering with this study (e.g. omega-3, fish oil etc.) within 2 weeks prior to study start or during study
• Intake of anticoagulants (ASS, Heparin, Marcumar, etc.)
• General Safety & Laboratory Exclusion Criteria. Patients will be excluded from the study based on the following criteria:
- Hemoglobin: <11.0 g/dL (women); <12.0 g/dL (men)
- Platelets: <120 x 10^3/µL
- Leukocytes <3 x 10^3/mm3
- AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
or further for this study clinically relevant abnormal laboratory findings at screening
• Are unwilling to abstain from choline-rich foods (e.g. eggs, liver) 3 days prior to blood sampling at V1a and V2a.
• Pregnancy, breast feeding or intention to become pregnant during the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of AUC0-24h of choline after ingestion of krill oil (Superba Boost) and choline bitartrate. Free choline is measured in the plasma samples at 0 h, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h and 24 h. The pharmacokinetic parameters will be determined from the concentration time curves.
- Secondary Outcome Measures
Name Time Method Comparison of the pharmakokinetic endpoints AUC0-12h, Cmax und Tmax between products.<br>Comparison of concentration time profiles with the profile after intake of fish oil. <br>Additionally, further parameters of choline metabolism will be measured.