Effects of NSK-SD (Nattokinase) on Blood Pressure

NCT ID: NCT02886507

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NSK-SD (nattokinase)

One capsule (100 mg) nattokinase/day for the 8-week study duration.

Group Type: ACTIVE_COMPARATOR

NSK-SD (nattokinase)

Intervention Type: DIETARY_SUPPLEMENT

Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.

Placebo

One capsule placebo/day for the 8-week study duration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo capsules contain microcrystalline cellulose.

Interventions

NSK-SD (nattokinase)

Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo capsules contain microcrystalline cellulose.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JBSL-USA Incorporated

INDUSTRY

Sponsor Role: collaborator

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Gitte Jensen, Ph.D.

Research director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gitte S Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Other Identifiers

NIS 087-001

Identifier Type: -

Identifier Source: org_study_id