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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.
Previous randomized double blinded placebo-controlled studies on the consumption of the fibrinolytic enzyme Nattokinase and NSK-SD is transported across the gut [Fujita et al., 1995], and has shown multiple effects on vascular health, including fibrinolytic effects [Sumi et al., 1990; Fujita et al., 1995] and regulation of blood pressure [Kim et al., 2008].
A previous study on effects on blood pressure [Kim et al., 2008], involved 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 8 weeks of 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
NSK-SD (nattokinase), Placebo
Natural Immune Systems Inc
Published on BioPortfolio: 2016-09-01T14:53:21-0400
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