Clinical trial NCT02886507: Effects of NSK-SD (Nattokinase) on Blood Pressure
Official title: Effects of NSK-SD (Nattokinase) on Blood Pressure. A Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
Collaborators: name: JBSL-USA Incorporated
First posted: 2016-09-01
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Reduction of hypertension
timeFrame: Eight weeks
Secondary outcomes:
measure: von Willebrand factor
timeFrame: Eight weeks
measure: Plasma renin activity
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: NIS Labs
name: Gitte S Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: