NCT02913170已完成4 期
Nattokinase Supplementation and Hemostatic Factors
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Collagen-epinephrine closure time at baseline
研究概览
简要总结
The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 69 years
- •Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
- •Nondiabetic (fasting blood glucose < 126mg/dL and 2-hour blood glucose < 200mg/dL)
排除标准
- •Use of any medication or supplements
- •Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
- •Women who were pregnant, breastfeeding or intending to become pregnant during the study period
- •Drug or alcohol abuse
结局指标
主要结局
Collagen-epinephrine closure time at baseline
时间窗: baseline
Collagen-epinephrine closure time at 8-week follow-up
时间窗: 8-week follow-up
次要结局
- Prothrombin time at baseline(baseline)
- Activated partial thromboplastin time at 8-week follow-up(8-week follow-up)
- Prothrombin time at 8-week follow-up(8-week follow-up)
- Activated partial thromboplastin time at baseline(baseline)
- Fibrinogen concentration at baseline(baseline)
- Fibrinogen concentration at 8-week follow-up(8-week follow-up)
研究者
研究点 (2)
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