Effects of NSK-SD (Nattokinase) on Blood Pressure

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: NSK-SD (nattokinase)

• Registration Number: NCT02886507
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One capsule placebo/day for the 8-week study duration.
NSK-SD (nattokinase)	NSK-SD (nattokinase)	One capsule (100 mg) nattokinase/day for the 8-week study duration.

Primary Outcome Measures

Name	Time	Method
Reduction of hypertension	Eight weeks

Secondary Outcome Measures

Name	Time	Method
von Willebrand factor	Eight weeks
Plasma renin activity	Eight weeks