Nattokinase Supplementation and Hemostatic Factors

NCT ID: NCT02913170

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-09-30

Brief Summary

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The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nattokinase group

A nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal.

Group Type EXPERIMENTAL

Nattokinase

Intervention Type DIETARY_SUPPLEMENT

Placebo group

A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nattokinase

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 69 years
* Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
* Nondiabetic (fasting blood glucose \< 126mg/dL and 2-hour blood glucose \< 200mg/dL)

Exclusion Criteria

* Use of any medication or supplements
* Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment
* Women who were pregnant, breastfeeding or intending to become pregnant during the study period
* Drug or alcohol abuse
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Ho Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NP_intervention

Identifier Type: -

Identifier Source: org_study_id

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