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Effects of NSK-SD (Nattokinase) on Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886507
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
JBSL-USA Incorporated
Information provided by (Responsible Party):
Gitte Jensen, Ph.D., Natural Immune Systems Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: NSK-SD (nattokinase) Dietary Supplement: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of hypertension [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. von Willebrand factor [ Time Frame: Eight weeks ]
  2. Plasma renin activity [ Time Frame: Eight weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886507


Sponsors and Collaborators
Natural Immune Systems Inc
JBSL-USA Incorporated
Investigators
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Principal Investigator: Gitte S Jensen, PhD NIS Labs
More Information
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Responsible Party: Gitte Jensen, Ph.D., Research director, Natural Immune Systems Inc
ClinicalTrials.gov Identifier: NCT02886507    
Other Study ID Numbers: NIS 087-001
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Manuscript publication.
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases