Dose-finding Study for Vitamin K2 in Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- undercarboxylated osteocalcin (ucOC)
研究概览
简要总结
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.
The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.
详细描述
This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:
Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.
Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.
During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between 18 and 45 years of age.
- •Subjects of normal body weight and height according to BMI < 30
- •Subject has given written consent to take part in the study
排除标准
- •Subjects with (a history of) metabolic or gastrointestinal disease
- •Subject with (a history of) soy allergy
- •Subjects using vitamin supplements containing vitamin K
- •Subjects presenting chronic inflammatory diseases
- •Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- •Subjects receiving corticoϊd treatment
- •Subjects using oral anticoagulants
研究组 & 干预措施
MK7_180
MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
MK7_90
MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
MK7_10
MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
PLACEBO
MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks.
干预措施: Placebo (Dietary Supplement)
MK7_20
MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
MK7_360
MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
MK7_45
MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
干预措施: MK7 (Dietary Supplement)
结局指标
主要结局
undercarboxylated osteocalcin (ucOC)
时间窗: 12 weeks
UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)
次要结局
- carboxylated osteocalcin (cOC)(12 weeks)
- undercarboxylated matrix-gla protein (ucMGP)(12 weeks)