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Efficacy and Safety of Geneferm Nattokinase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00749801
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : September 9, 2008
Sponsor:
Collaborator:
GeneFerm Biotechnology Co., Ltd.
Information provided by:
Chi Mei Medical Hospital

Study Description
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Brief Summary:
Nattokinase, first found by Dr. Hiroyuki Sumi in 1980, is a potent fibrinolytic enzyme extracted from Natto, a popular soybean fermented food in Japan. It was confirmed that oral administration of nattokinase (or natto) produced a mild and frequent enhancement of the fibrinolytic activity in the plasma as indicated by the fibrinolytic parameters and the production of tissue plasminogen activator. Other studies also showed a reduction in lipid peroxidation and improvement of lipid metabolism. Short-term effect (less then 10 days) of oral administration of nattokinase on both animal and human subjects has been studied and reported. However, whether nattokinase possesses a beneficial effect to dyslipidemic patients remains unclear. The aim of this study is to investigate the long-term effect (six month) of the mono and multiple formulae of nattokinase, change of BP, lipid and fibrinolytic factors from baseline and 6 months on dyslipidemic patients.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Nattokinase Not Applicable

Detailed Description:

This study will employ a randomized, double-blind, placebo-controlled, parallel-group design. Adult men and women who met the inclusion/exclusion criteria and gave consent to participate were randomly assigned to one of the three groups: Group A: nattokinase-mono formula (18 subjects); Group B: nattokinase compound (multiple formulae) (18 subjects); Group C: placebo (10 subjects).

Laboratory tests, including TG, total cholesterol, LDL-C, HDL-C, fibrinogen, D-Dimer, uric acid, vital signs and body weight will be evaluated at screening visit, 1 month, 3 months, 6 months visits after the initiation of treatment. Vital signs and body weight will be measured at every visits.

Patient self-evaluation of tolerance and physical improvement will be assessed by a Patient Questionnaire at each visit. Each patient will be carefully monitored for the development of any adverse events (AE).

The change of all lab tests and vital signs will be plotted and compared against time. Wilcoxon Signed-Rank test will be performed to compare the baseline and 6 months after the initiation of administration. Change from baseline for all lab and vital evaluations will be compared among three groups by Analysis of Variance (ANOVA) followed by LSD multiple comparison.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Comparison Study to Evaluate the Efficacy and Safety of Oral Administration of Nattokinase (From GeneFerm Biotechnology Co., Ltd.) Taken by Dyslipidemia Patients
Study Start Date : May 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
nattokinase-mono formula (3500FU)
 Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
  • nattokinase-mono formula (3500FU)
  • Nattokinase compound-multiple formulae
  • Placebo
Experimental: B
Nattokinase compound-multiple formulae
 Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
  • nattokinase-mono formula (3500FU)
  • Nattokinase compound-multiple formulae
  • Placebo
Placebo Comparator: C
Placebo
 Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
  • nattokinase-mono formula (3500FU)
  • Nattokinase compound-multiple formulae
  • Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Fibrinogen, FDP (fibrin degradation product), D-dimer, Total cholesterol, LDL-C (Low-density lipoprotein cholesterol), HDL-C (High-density lipoprotein cholesterol), Triglyceride (TG), and Uric acid [ Time Frame: screening, day 0, weeks 4, 13, 26 ]

Secondary Outcome Measures :
  1. Vital signs and self-evaluated questionnaire [ Time Frame: screening, day 0, weeks 4, 13, 26 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and non-pregnant women above 40 years of age.
  2. Dyslipidemic currently being untreated with lipid-lowering drugs. Dyslipidemia is defined as: Total cholesterol 200~300 mg/dl; or Triglyceride 200~500 mg/dl; or Low density lipoprotein-cholesterol 130~200 mg/dl; or High density lipoprotein cholesterol <40 mg/dl (male) and <50 mg/dl (female).
  3. Subjects who are, in the opinion of the Investigator, able to comply with the requirements of the study.
  4. 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.

Exclusion Criteria:

  1. Receipt of lipid-lowering drugs or device within 12 weeks.
  2. Myocardial infarction within the preceding 12 weeks.
  3. Recent major trauma (within 12 weeks).
  4. Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
  5. Recent hospitalization (within 12 weeks).
  6. Acute infection requiring current antibiotic therapy.
  7. Recent or abrupt change (within 1 month) in usual diet.
  8. Unstable medical condition or life expectancy less than 6 months.
  9. Known allergies to the component of study product.
  10. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
  11. Total cholesterol >300 mg/dl; or Triglyceride >500 mg/dl; or Low density lipoprotein-cholesterol >200 mg/dl.
  12. Current use of warfarin.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749801


Locations
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Taiwan
Chi Mei Medical Hospital
Tainan, Taiwan, 710
Sponsors and Collaborators
Chi Mei Medical Hospital
GeneFerm Biotechnology Co., Ltd.
Investigators
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Study Chair: Nae-Cherng Yang, PhD Chung Chou Institute of Technology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nae-Cherng Yang, Chungchou Institute of Technology, Changhua, Taiwan
ClinicalTrials.gov Identifier: NCT00749801    
Other Study ID Numbers: Geneferm-N01
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008
Keywords provided by Chi Mei Medical Hospital:
drug naive
Dyslipidemic
nattokinase
fibrinolytic
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases