Effects of NSK-SD (Nattokinase) on Blood Pressure

NCT02886507 | Completed Phase 4

• 1 other identifier: NIS 087-001
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction of hypertension

  Eight weeks

Secondary Outcomes (2)

• von Willebrand factor

  Eight weeks

• Plasma renin activity

  Eight weeks

Study Arms (2)

NSK-SD (nattokinase)

ACTIVE COMPARATOR

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

Dietary Supplement: NSK-SD (nattokinase)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

NSK-SD (nattokinase) DIETARY_SUPPLEMENT

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

NSK-SD (nattokinase)

Placebo DIETARY_SUPPLEMENT

The placebo capsules contain microcrystalline cellulose.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead
• JBSL-USA Incorporated: collaborator

MeSH Terms

Conditions

Hypertension

Interventions

nattokinase

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gitte S Jensen, PhD

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share