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Completed

NCT Number: NCT02886507

Effects of NSK-SD (Nattokinase) on Blood Pressure

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NSK-SD (nattokinase)

Dietary Supplement

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

Placebo

Dietary Supplement

The placebo capsules contain microcrystalline cellulose.

Primary outcomes

  1. Reduction of hypertension

    Time frame: Eight weeks

Secondary outcomes

  1. von Willebrand factor

    Time frame: Eight weeks

  2. Plasma renin activity

    Time frame: Eight weeks

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Collaborators

  • JBSL-USA Incorporated

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2016
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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