Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- serum level menaquinone-7
研究概览
简要总结
Previous studies have indicated 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, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 y
- •Normal body weight and height (BMI <30 kg/m2)
- •Stable body weight (weight gain or loss <3 kg in past 3 mo)
- •Caucasian race
- •Written consent to take part in the study
- •Low vitamin K status
排除标准
- •(A history of) metabolic or gastrointestinal diseases
- •Chronic degenerative and/or inflammatory diseases
- •Abuse of drugs and/or alcohol
- •Use of corticosteroids
- •Use of oral anticoagulants
- •(A history of) soy allergy
- •Use of vitamin K-containing multivitamins or vitamin K supplements
- •Blood donation or participation in another study within one month before the study
结局指标
主要结局
serum level menaquinone-7
时间窗: 8 weeks
次要结局
- plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin(8 weeks)