Comparison of Bioavailability of Three Different Vitamin K2 Formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- MK-7 absorption profiles
研究概览
简要总结
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
详细描述
Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, aged between 20 and 40 years
- •Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
- •Stable body weight (weight gain or loss < 3 kg in past 3 mo)
- •Written consent to take part in the study
- •Agreement to adhere to dietary restrictions required by the protocol
排除标准
- •Abuse of drugs and/or alcohol
- •Use of vitamin supplements containing vitamin K
- •Soy allergy
- •Pregnancy
- •a history of) metabolic or gastrointestinal diseases including hepatic disorders
- •Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
- •Use of oral anticoagulants
- •Corticoid treatment
- •Subjects with anaemia or subjects who recently donated blood or plasma
- •Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)
结局指标
主要结局
MK-7 absorption profiles
时间窗: 9 weeks
The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.
次要结局
未报告次要终点