Effects of NSK-SD (Nattokinase) on Blood Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: NSK-SD (nattokinase); Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of hypertension	Eight weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Collaborators: JBSL-USA Incorporated
• Investigators: Principal Investigator: Gitte S Jensen, PhD, NIS Labs

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NIS 087-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Manuscript publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No