NL-OMON51421已完成不适用
Antioxidant and immune effects of vitamin K2 - ProteK2t study
Kappa Bioscience AS0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- •Age >=50 and <=75;
- •Self-reported postmenopausal (at least one year after the final menstruation)
- •BMI >=25 and <=32 kg/m2;
- •Plasma dp-ucMGP concentration in highest 50-66% of the screened population
- •Non-smoking (defined as not smoking currently and not having smoked (at all)
- •in the year before study start);;
- •Healthy as assessed by health questionnaire (*Gezondheidsvragenlijst*) and
- •according to the judgment of the study physician;
- •Voluntary participation;
- •Having given written informed consent;
- •Willing to comply with study procedures;
- •Accept use of all encoded data, including publication, and the confidential
- •use and storage of all data for 15 years;
排除标准
- •Plasma dp-ucMGP concentration >1000 pmol/L at screening
- •Treatment with oral antibiotics within 2 months of the start of the study
- •Any vaccination in the month before study start or any scheduled vaccination
- •during the study period
- •Use of antioxidant or vitamin K and D supplements;
- •Use of antioxidant or vitamin K and D supplements in the 3 months before the
- •start of the study;
- •Use of aspirin or medication with established antioxidant or
- •anti-inflammatory properties;
- •Use of medication that interferes with vitamin K or blood coagulation;
- •Use of statins to reduce level of low-density lipoprotein cholesterol in the
- •Hyperlipidaemia, diabetes, hypertension, intestinal disease, diseases with an
- •inflammation component;
- •Hormone replacement therapy in women;
- •Follow a vegetarian or vegan diet;
- •Participation in any clinical trial including blood sampling and/or
- •administration of substances up to 30 days before day 1 of this study;
- •Alcohol consumption for men > 28 units/week and >4/day; for women: >21
- •units/week and >3/day;
- •Reported unexpected weight loss or weight gain of > 3 kg in the month prior
- •to pre-study screening, or intention to lose weight during the study period;
- •Reported slimming or medically prescribed diet;
- •Recent blood donation (<1 month prior to Day 01 of the study);
- •Not willing to give up blood donation during the study;
- •Personnel of NIZO food research, EB Medical Research and Kappa Bioscience,
- •their partner and their first and second degree relatives;
- •Not having a general practitioner;
- •Not willing to accept information-transfer concerning participation in the
- •study, or information regarding his or her health, like laboratory results and
- •eventual adverse events to and from his general practitioner
研究者
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