NL-OMON46101撤回2 期
A randomized pilot study on probiotics and their effect on vitamin K2 status - ProVitaK
Winclove B.V.0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* High cardiovascular risk without type 2 diabetes * at least 1 of the following risk factors:
- •o systolic blood pressure > 140mm Hg, diastolic blood pressure > 90 mmHg or use of blood pressure lowering medication and/or
- •o impaired glucose tolerance * 2 hour glucose levels of 7.8 to 11.0 mmol/L after 75 gram oral glucose tolerance test
- •o Family history of cardiovascular disease < 65 years
- •o Total cholesterol > 6.5 mmol/l or use of statins
- •o Smokers * 50 years
- •o Estimated glomerular filtration rate < 60 ml/min
- •* No gastrointestinal tract problems/stool problems
排除标准
- •* Pregnancy, lactation or a female planning to conceive within the study period
- •* Diabetes of any type.
- •* Age <50 or * 70 years
- •* Body mass index < 20 or > 39 kg/m2
- •* Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomization.
研究者
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