NL-OMON55095已完成2 期
A randomized study on probiotics and their effect on vitamin K2 status - PROVITAK
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- •Higher 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 Non-fasting glucose >=7.8 and <11.1mmol/l.
- •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 > 30 and < 60 ml/min
排除标准
- •Pregnancy, lactation or a female planning to conceive within the study period
- •Any significant medical reason for exclusion as determined by the investigator
- •Unable to give written informed consent
- •Unable to speak, read and/or write Dutch
- •Diabetes of any type.
- •Age <50 or >75 years
- •Body mass index < 20 or > 39 kg/m2
- •Using vitamin supplements that contain vitamin K, or unwilling to stop
- •Using probiotic supplements
- •Natto or goose liver consumers
- •Use of vitamin K antogonists such as warfarin, acenocoumarol or coumarin
- •Use of antibiotics
- •Colectomy
- •Crohn's disease/ colitis Ulcerosa
- •Use of more than 3 alcoholic beverages per day
研究者
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