Comparison of Absorption of Vitamin K2 Human Study Gelpell
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.
研究概览
简要总结
From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.
This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between 20 and 30 years old
- •Subjects of normal body weight and height according to BMI < 30
- •Subjects of Caucasian race
- •Subject has given written consent to take part in the study
排除标准
- •Subjects with (a history of) metabolic or gastrointestinal disease
- •Subjects presenting chronic degenerative and/or inflammatory disease
- •Subjects receiving corticoϊd treatment
- •Subjects using oral anticoagulants
- •Subject with (a history of) soy allergy
- •Subjects using vitamin K containing multivitamins or vitamin K supplements
- •Subjects with anaemia or subjects who recently donate blood.
研究组 & 干预措施
1
softgel capsules
干预措施: Vitamin K2 in softgel (Dietary Supplement)
2
Gelpell capsules
干预措施: Vitamin K2 in Gelpell (Dietary Supplement)
结局指标
主要结局
The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.
时间窗: 4 weeks
次要结局
- The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.(4 weeks)