Efficacy and Safety of Natto Extract

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Changhua Christian Hospital

Criteria

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:

1. Subjects have no risk factors of cardiovascular diseases (see Group C) or chronic renal diseases in the history.

2. 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:

1. Patients have coronary artery disease (CAD); OR

2. Patients have peripheral arterial occlusive disease (PAOD); OR

3. Patients have history of stroke; OR

4. Patients have history of transient ischemic attack (TIA); OR

5. Patients have history of pulmonary embolism (PE); OR

6. Patients have history of deep vein thrombosis (DVP); OR

7. 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:

1. Patients have coronary artery disease (CAD).

2. Patients have peripheral arterial occlusive disease (PAOD).

3. Patients have history of stroke.

4. Patients have history of transient ischemic attack (TIA).

5. Patients have history of pulmonary embolism (PE).

6. Patients have history of deep vein thrombosis (DVP).

7. 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.

8. Patients have history of chronic renal diseases.

9. Male subjects have Creatinine>1.4 mg/dl; Female>1.3 mg/dl.