Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- carboxylation of osteocalcin
研究概览
简要总结
The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.
The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.
详细描述
Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, aged between 20-80 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
- •Pregnancy
- •(a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis
- •Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease
- •Use of oral anticoagulants, drugs or hormones that influence bone metabolism
- •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
carboxylation of osteocalcin
时间窗: 12 weeks
The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.
次要结局
- carboxylation of matrix-gla protein(12 weeks)