NCT00749801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

September 9, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

September 8, 2008

Last Update Submit

September 8, 2008

Conditions

Hyperlipidemia

Keywords

drug naiveDyslipidemicnattokinasefibrinolytic

Outcome Measures

Primary Outcomes (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

    screening, day 0, weeks 4, 13, 26

Secondary Outcomes (1)

  • Vital signs and self-evaluated questionnaire

    screening, day 0, weeks 4, 13, 26

Study Arms (3)

A

ACTIVE COMPARATOR

nattokinase-mono formula (3500FU)

Drug: Nattokinase

B

EXPERIMENTAL

Nattokinase compound-multiple formulae

Drug: Nattokinase

C

PLACEBO COMPARATOR

Placebo

Drug: Nattokinase

Interventions

NattokinaseDRUG

2 capsules in the morning and before bed-time daily

Also known as: nattokinase-mono formula (3500FU), Nattokinase compound-multiple formulae, Placebo
ABC

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi Mei Medical Hospital

Tainan, 710, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 19786378DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

nattokinase

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nae-Cherng Yang, PhD

    Chung Chou Institute of Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

May 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

September 9, 2008

Record last verified: 2008-09

Locations

TW(1)