Comparative Study of Three Delivery Systems of Menaquinone-7
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The change in plasma MK-7 concentration after intervention between the three study groups
研究概览
简要总结
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.
详细描述
In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.
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
- None
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 with body weight and height according to BMI between 20 and 30 kg/m2
- •Subjects of Caucasian race
- •Subject has given written consent to take part in the study
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 corticosteroid 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
研究组 & 干预措施
basic yogurt enriched with MK-7
one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)
干预措施: basic yogurt enriched with MK-7 (Dietary Supplement)
MK-7 containing capsule
one study group will receive daily a softgel capsule consisting of 50 μg MK-7
干预措施: MK-7 containing capsule (Dietary Supplement)
nutrient enriched yogurt with MK-7
one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil)
干预措施: nutrient-enriched yogurt with MK-7 (Dietary Supplement)
结局指标
主要结局
The change in plasma MK-7 concentration after intervention between the three study groups
时间窗: baseline and 6 weeks
次要结局
- The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.(baseline and 6 weeks)