Efficacy and Safety of Natto Extract

This study has been completed.
Sponsor:
Information provided by:
Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT00447434
First received: March 13, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Thrombosis
Cardiovascular Diseases
Drug: Natto extract (Nattokinase)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • fibrinolytic factors
  • vital signs
  • blood lipids

Secondary Outcome Measures:
  • renal function
  • body weight
  • self-administered questionnaire

Estimated Enrollment: 45
Study Start Date: June 2005
Estimated Study Completion Date: October 2005
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).

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447434

Locations
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
Investigators
Principal Investigator: Chien-Hsun Hsia, MD Changhua Christian Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447434     History of Changes
Other Study ID Numbers: I050308
Study First Received: March 13, 2007
Last Updated: March 13, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Changhua Christian Hospital:
Nattokinase
fibrinolytic factors
blood lipids
nutrimental supplement

Additional relevant MeSH terms:
Cardiovascular Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014