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Efficacy and Safety of Natto Extract

Primary Purpose

Thrombosis, Cardiovascular Diseases

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Natto extract (Nattokinase)

About this trial

This is an interventional prevention trial for Thrombosis focused on measuring Nattokinase, fibrinolytic factors, blood lipids, nutrimental supplement

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

In order to be enrolled in the study, potential study subjects must meet the following inclusion criteria:
1. Men and non-pregnant women who are at least 20 and younger than 70 years of age.
2. Subjects who are, in the opinion of the Investigator, able to comply with the requirements of the study.
3. Subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving investigational product.

Group-specific inclusions criteria:

Group A:

Subjects have no risk factors of cardiovascular diseases (see Group C) or chronic renal diseases in the history.
Male subjects have Creatinine≦1.4 mg/dl; Female≦1.3 mg/dl.

Group B:

1. Patients have been receiving dialysis at the same institute for at least 3 months.

Group C:

Patients have coronary artery disease (CAD); OR
Patients have peripheral arterial occlusive disease (PAOD); OR
Patients have history of stroke; OR
Patients have history of transient ischemic attack (TIA); OR
Patients have history of pulmonary embolism (PE); OR
Patients have history of deep vein thrombosis (DVP); OR
Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc.

Exclusion Criteria:

In order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria:
1. Known allergies to the component of study product.
2. Current use of warfarin.
3. Patients have active disease status.
4. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.

Group-specific exclusion criteria:

Group A:

Patients have coronary artery disease (CAD).
Patients have peripheral arterial occlusive disease (PAOD).
Patients have history of stroke.
Patients have history of transient ischemic attack (TIA).
Patients have history of pulmonary embolism (PE).
Patients have history of deep vein thrombosis (DVP).
Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc.
Patients have history of chronic renal diseases.
Male subjects have Creatinine>1.4 mg/dl; Female>1.3 mg/dl.

Sites / Locations

Changhua Christian Hospital

Outcomes

Primary Outcome Measures

fibrinolytic factors

vital signs

blood lipids

Secondary Outcome Measures

renal function

body weight

self-administered questionnaire

Full Information

NCT ID

NCT00447434

First Posted

March 13, 2007

Last Updated

March 13, 2007

Sponsor

Changhua Christian Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00447434

Brief Title

Efficacy and Safety of Natto Extract

Official Title

An Open-Label, Parallel Comparison Study to Evaluate the Effect of Oral Administration of Nattokinase Taken by Normal Subjects, Patients Under Dialysis, and Patients of Cardiovascular High Risk Groups

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Changhua Christian Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Nattokinase is a potent fibrinolytic enzyme extracted from Natto. The objective of this study was to compare the efficacy of the natto extract taken by healthy volunteers, dialysis patients, and patients with cardiovascularrisk factors on the fibrinolytic factors and blood lipids. The study has two primary objectives: to evaluate the effect of oral intake of nattokinase in normal subjects, patients under dialysis, and patients of cardiovascular high risk group, and to compare the effect of oral intake of nattokinase among three groups. Fifteen subjects, 20-70 years, for each group will be enrolled to take the capsules of natto extract orally for 2 months. Fibrinolytic factors, vital signs and blood lipids for efficacy, and body weight, renal function and self-administered questionnaire for safety will be assessed at screening, 3, 7, 28, and 56 days after the initiation of intake, and 2 weeks after the cease of intake.

Detailed Description

This study will employ an open-label, parallel-group design. Adult men and women who meet the inclusion/exclusion criteria and give written consent to participate will be assigned to one of the three groups according to their condition: Group A- normal volunteers; Group B- patients under dialysis; Group C- patients of cardiovascular high risk group. Each group will enroll 15 subjects. After two to four weeks run-in period, subjects will be given nattokinase orally for 8 weeks, and will be asked to stop taking nattokinase for 2 weeks to evaluate the effect of long-term intake and cease of intake of nattokinase. Laboratory tests, including fibrinogen, T-PA, PAI-1, D-dimer, total cholesterol, LDL-C, HDL-C, and TG, vital signs and body weight will be evaluated at screening visit, 3 days, 1 week, 4 weeks, 8 weeks, and 10 weeks (2 weeks after cease of intake) visits. Patient self-evaluation of tolerance and physical improvement will be assessed by a Patient Questionnaire at 3-day, and 1-, 4-, 8-, and 10-week visits. Each patient will be carefully monitored for the development of any adverse events (AE).

6. Conditions and Keywords

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

Thrombosis, Cardiovascular Diseases

Keywords

Nattokinase, fibrinolytic factors, blood lipids, nutrimental supplement

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Natto extract (Nattokinase)

Primary Outcome Measure Information:

Title

fibrinolytic factors

Title

vital signs

Title

blood lipids

Secondary Outcome Measure Information:

Title

renal function

Title

body weight

Title

self-administered questionnaire

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In order to be enrolled in the study, potential study subjects must meet the following inclusion criteria: Men and non-pregnant women who are at least 20 and younger than 70 years of age. Subjects who are, in the opinion of the Investigator, able to comply with the requirements of the study. Subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving investigational product. Group-specific inclusions criteria: Group A: Subjects have no risk factors of cardiovascular diseases (see Group C) or chronic renal diseases in the history. Male subjects have Creatinine≦1.4 mg/dl; Female≦1.3 mg/dl. Group B: 1. Patients have been receiving dialysis at the same institute for at least 3 months. Group C: Patients have coronary artery disease (CAD); OR Patients have peripheral arterial occlusive disease (PAOD); OR Patients have history of stroke; OR Patients have history of transient ischemic attack (TIA); OR Patients have history of pulmonary embolism (PE); OR Patients have history of deep vein thrombosis (DVP); OR Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc. Exclusion Criteria: In order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria: Known allergies to the component of study product. Current use of warfarin. Patients have active disease status. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study. Group-specific exclusion criteria: Group A: Patients have coronary artery disease (CAD). Patients have peripheral arterial occlusive disease (PAOD). Patients have history of stroke. Patients have history of transient ischemic attack (TIA). Patients have history of pulmonary embolism (PE). Patients have history of deep vein thrombosis (DVP). Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc. Patients have history of chronic renal diseases. Male subjects have Creatinine>1.4 mg/dl; Female>1.3 mg/dl.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chien-Hsun Hsia, MD

Organizational Affiliation

Changhua Christian Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

12. IPD Sharing Statement

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Efficacy and Safety of Natto Extract

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