Nattokinase Supplementation and Hemostatic Factors

September 22, 2016 updated by: Jong Ho Lee, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-749
        • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Nattokinase
Placebo Comparator: Placebo group
A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collagen-epinephrine closure time at baseline
Time Frame: baseline
baseline
Collagen-epinephrine closure time at 8-week follow-up
Time Frame: 8-week follow-up
8-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prothrombin time at baseline
Time Frame: baseline
baseline
Prothrombin time at 8-week follow-up
Time Frame: 8-week follow-up
second
8-week follow-up
Activated partial thromboplastin time at baseline
Time Frame: baseline
baseline
Activated partial thromboplastin time at 8-week follow-up
Time Frame: 8-week follow-up
8-week follow-up
Fibrinogen concentration at baseline
Time Frame: baseline
mg/dL
baseline
Fibrinogen concentration at 8-week follow-up
Time Frame: 8-week follow-up
mg/dL
8-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jong Ho Lee, Ph.D., Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP_intervention

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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