NCT05675163已完成不适用
Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study
NIZO Food Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- plasma ox-LDL
研究概览
简要总结
The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 the health questionnaire and according to the judgment of the study physician;
- •Voluntary participation;
- •Having given written informed consent;
- •Willing to comply with study procedures;
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 month 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 blood;
- •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;
结局指标
主要结局
plasma ox-LDL
时间窗: 3 weeks
Dose dependent change in ox-LDL levels
次要结局
- plasma CRP(3 weeks)
- IL-6(3 weeks)
- plasma MDA(3 weeks)
- Phagocytosis capacity(3 weeks)
- PBMC gene expression(3 weeks)
研究者
Alwine Kardinaal
Principal Scientist Nutrition & Health
NIZO Food Research
研究点 (1)
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