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Efficacy and Safety of Geneferm Nattokinase

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Nattokinase

About this trial

This is an interventional supportive care trial for Hyperlipidemia focused on measuring drug naive, Dyslipidemic, nattokinase, fibrinolytic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chi Mei Medical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

nattokinase-mono formula (3500FU)

Nattokinase compound-multiple formulae

Placebo

Outcomes

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

Secondary Outcome Measures

Vital signs and self-evaluated questionnaire

Full Information

NCT ID

NCT00749801

First Posted

September 8, 2008

Last Updated

September 8, 2008

Sponsor

Chi Mei Medical Hospital

Collaborators

GeneFerm Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00749801

Brief Title

Efficacy and Safety of Geneferm Nattokinase

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 Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chi Mei Medical Hospital

Collaborators

GeneFerm Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

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

Hyperlipidemia

Keywords

drug naive, Dyslipidemic, nattokinase, fibrinolytic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

nattokinase-mono formula (3500FU)

Arm Title

Arm Type

Experimental

Arm Description

Nattokinase compound-multiple formulae

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Nattokinase

Other Intervention Name(s)

nattokinase-mono formula (3500FU), Nattokinase compound-multiple formulae, Placebo

Intervention Description

2 capsules in the morning and before bed-time daily

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Vital signs and self-evaluated questionnaire

Time Frame

screening, day 0, weeks 4, 13, 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nae-Cherng Yang, PhD

Organizational Affiliation

Chung Chou Institute of Technology

Official's Role

Study Chair

Facility Information:

Facility Name

Chi Mei Medical Hospital

City

Tainan

ZIP/Postal Code

710

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19786378

Citation

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.

Results Reference

derived

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Efficacy and Safety of Geneferm Nattokinase

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