Effects of NSK-SD (Nattokinase) on Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: NSK-SD (nattokinase)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSK-SD (nattokinase)<br>One capsule (100 mg) nattokinase/day for the 8-week study duration. | Dietary Supplement: NSK-SD (nattokinase)<br>* Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.<br>|
| Placebo Comparator: Placebo<br>One capsule placebo/day for the 8-week study duration. | Dietary Supplement: Placebo<br>* The placebo capsules contain microcrystalline cellulose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hypertension |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| von Willebrand factor |  | Eight weeks | 
| Plasma renin activity |  | Eight weeks |