The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- undercarboxylated and carboxylated matrix-gla protein
研究概览
简要总结
In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.
详细描述
In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and postmenopausal women between 45 and 65 years old
- •Subjects of body weight and height according to BMI between 23 and 30 kg/m2
- •Subjects of Caucasian race
- •Subject has given written consent to take part in the study
- •Low vitamin K-status
排除标准
- •Subjects with hypertension
- •Subjects with hypercholesterolemia
- •Subjects with (a history of) metabolic or gastrointestinal disease
- •Subjects presenting chronic degenerative and/or inflammatory disease
- •Subjects with (a history) of diabetes mellitus
- •Abuse of drugs and/or alcohol
- •Subjects receiving corticosteroϊd treatment
- •Subjects using oral anticoagulants and subjects with clotting disorders
- •Subjects using blood pressure lowering medication
- •Subjects using cholesterol-lowering medication
- •Subjects using multivitamins or vitamin K supplements
- •Subjects consuming high amounts of vitamin K-containing food products
- •Subjects with cow's milk allergy and lactose intolerance
结局指标
主要结局
undercarboxylated and carboxylated matrix-gla protein
时间窗: 12 weeks
The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein
次要结局
- undercarboxylated and carboxylated osteocalcin(12 weeks)