Healthy volunteers
Conditions
Interventions
Group 1: Krill oil (Superb Boost), 8 g equivalent to 572 mg choline, single dose oral, 8 capsules
Group 2: Choline bitartrat (1500 mg, equivalent to 600 mg choline), single dose oral, 2 capsules
Group
Sponsors
Aker BioMarine Antarctic AS
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Comparison of the pharmakokinetic endpoints AUC0-12h, Cmax und Tmax between products. Comparison of concentration time profiles with the profile after intake of fish oil. Additionally, further parameters of choline metabolism will be measured. | — |
Countries
Germany
Contacts
Public ContactTanita Dharsono
BioTeSys GmbH
Outcome results
None listed