Efficacy and Safety of Geneferm Nattokinase - Full Text View

Purpose

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	Intervention
Hyperlipidemia	Drug: Nattokinase


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Chi Mei Medical Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital signs and self-evaluated questionnaire [ Time Frame: screening, day 0, weeks 4, 13, 26 ] [ Designated as safety issue: No ]


Enrollment:	47
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and non-pregnant women above 40 years of age.
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).
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.

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749801

Locations


Taiwan
Chi Mei Medical Hospital
Tainan, Taiwan, 710

Sponsors and Collaborators

Chi Mei Medical Hospital

GeneFerm Biotechnology Co., Ltd.

Investigators


Study Chair:	Nae-Cherng Yang, PhD	Chung Chou Institute of Technology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang NC, Chou CW, Chen CY, Hwang KL, Yang YC. Combined nattokinase with red yeast rice but not nattokinase alone has potent effects on blood lipids in human subjects with hyperlipidemia. Asia Pac J Clin Nutr. 2009;18(3):310-7.


Responsible Party:	Nae-Cherng Yang, Chungchou Institute of Technology, Changhua, Taiwan
ClinicalTrials.gov Identifier:	NCT00749801 History of Changes
Other Study ID Numbers:	Geneferm-N01
Study First Received:	September 8, 2008
Last Updated:	September 8, 2008
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chi Mei Medical Hospital:


drug naive Dyslipidemic nattokinase fibrinolytic

Additional relevant MeSH terms:


Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on September 26, 2016