NCT02886507

Effects of NSK-SD (Nattokinase) on Blood Pressure

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Natural Immune Systems Inc · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NSK-SD (nattokinase)	Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.
DIETARY_SUPPLEMENT	Placebo	The placebo capsules contain microcrystalline cellulose.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2016-09-01
• Last updated: 2016-09-01