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 - BTS1195/18

Aker BioMarine Antarctic AS0 个研究点目标入组 18 人开始时间: 2018年11月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

发起方