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Nattokinase Supplementation and Hemostatic Factors

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Nattokinase

Placebo

About this trial

This is an interventional supportive care trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nattokinase group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Collagen-epinephrine closure time at baseline

Collagen-epinephrine closure time at 8-week follow-up

Secondary Outcome Measures

Prothrombin time at baseline

Prothrombin time at 8-week follow-up

second

Activated partial thromboplastin time at baseline

Activated partial thromboplastin time at 8-week follow-up

Fibrinogen concentration at baseline

mg/dL

Fibrinogen concentration at 8-week follow-up

mg/dL

Full Information

NCT ID

NCT02913170

First Posted

September 20, 2016

Last Updated

September 22, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02913170

Brief Title

Nattokinase Supplementation and Hemostatic Factors

Official Title

Nattokinase Supplementation and Hemostatic Factors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nattokinase group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Nattokinase

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Collagen-epinephrine closure time at baseline

Time Frame

baseline

Title

Collagen-epinephrine closure time at 8-week follow-up

Time Frame

8-week follow-up

Secondary Outcome Measure Information:

Title

Prothrombin time at baseline

Time Frame

baseline

Title

Prothrombin time at 8-week follow-up

Description

second

Time Frame

8-week follow-up

Title

Activated partial thromboplastin time at baseline

Time Frame

baseline

Title

Activated partial thromboplastin time at 8-week follow-up

Time Frame

8-week follow-up

Title

Fibrinogen concentration at baseline

Description

mg/dL

Time Frame

baseline

Title

Fibrinogen concentration at 8-week follow-up

Description

mg/dL

Time Frame

8-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Ho Lee, Ph.D.

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

City

Seoul

ZIP/Postal Code

120-749

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Nattokinase Supplementation and Hemostatic Factors

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