Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Reduction of hypertension
研究概览
简要总结
This is a randomized double-blinded placebo-controlled study to evaluate the effects of NSK-SD consumption in subjects with Stage I hypertension.
The study population will be randomized into two groups, where both groups will receive dietary and lifestyle recommendations to help reduce hypertension. One group will receive placebo and the other group NSK-SD for 8 weeks.
The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of treatment in the two subject groups.
详细描述
Previous randomized double blinded placebo-controlled studies on the consumption of the fibrinolytic enzyme Nattokinase and NSK-SD is transported across the gut, and has shown multiple effects on vascular health, including fibrinolytic effects and regulation of blood pressure.
A previous study on effects on blood pressure was conducted in an Asian population involving 86 people, where 73 people completed the study requirements (39 in the NSK-SD group, 34 in the placebo group). The data showed statistically significant reduction in both systolic and diastolic blood pressure after consumption of Nattokinase, whereas the changes after consuming placebo were not significantly different from baseline.
The objective of this study is to evaluate the effects of consumption of nattokinase on hypertension in a North American hypertensive population with associated genetic, dietary, and lifestyle factors. This is in extension of, and contrast to, previous studies in Asian populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults of both genders;
- •Age 18-85 years;
- •Elevated blood pressure as identified by:
- •Systolic blood pressure 130mmHg or higher, or diastolic blood pressure 90mmHg or higher;
- •Confirmed on three separate occasions.
排除标准
- •Use of Nattokinase-containing supplements within 60 days prior to enrollment;
- •Currently on blood pressure medication;
- •History of cancer chemotherapy within the last 12 months;
- •Significant active uncontrolled disease (such as lymphoma, cirrhosis, nephritis, uncompensated heart failure);
- •Consumption of more than an average of 2 standard alcoholic drinks/day (14 drinks per week)
- •Currently experiencing intense stressful events/ life changes that would negatively affect compliance;
- •Pregnant, nursing, or trying to become pregnant;
- •Women not using effective contraception;
- •Food allergies related to ingredients in test product.
结局指标
主要结局
Reduction of hypertension
时间窗: Eight weeks
次要结局
- von Willebrand factor(Eight weeks)
- Plasma renin activity(Eight weeks)
研究者
Gitte Jensen, Ph.D.
Research director
Natural Immune Systems Inc