Bioavailability of a food supplement in healthy
Conditions
Interventions
Group 1: Milk thistle + krill oil, single dose oral, 2 capsules
Group 2: Milk thistle, single dose oral, 2 capsules
Sponsors
Wörwag Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Healthy males or females (1:1) - BMI: 19 to 30 kg/m2 - Current Non-smoker - Participant is able and willing to sign the Informed Consent Form prior to screening evaluations - Participant is in good physical and mental health as established by medical history, vital signs, results of biochemistry, hematology - If applicable, stable intake of chronic medication of at least 4 weeks
Exclusion criteria
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, pancreas insufficiency, 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. milk thistle supplements, krill oil or fish oil products etc.) within 2 weeks prior to study start or during study - Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator’s opinion would impact participant safety - General Safety & Laboratory exclusion criteria: Patients will be excluded from the study based on the following criteria: Hemoglobin: 3 x Upper Limit of Normal - Blood donation within 1 month prior to study start or during study - Participants with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study - Pregnancy, breast feeding or intention to become pregnant during the study - Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study - A known allergy or hypersensitivity to any of the ingredients of the study products e.g. crustaceans and Asteraceae - Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Blood concentration-time curves of silybin (in plasma) and determination of iAUC (0-8h); timepoints: on visit 1 and 2 (pre, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h post single dose) - Comparison of iAUC (0-8h) of silybin between the study products; timepoints: on visit 1 and 2 (pre, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h post single dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Blood concentration-time curves of silybin (in plasma) and determination ?Cmax and Tmax - Comparison of ?Cmax and Tmax of silybin between the study products; | — |
Countries
Germany
Contacts
Public ContactDaniel Menzel
BioTeSys GmbH
Outcome results
None listed