UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027685 |
|---|---|
| Receipt number | R000031710 |
| Scientific Title | The effects of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise |
| Date of disclosure of the study information | 2017/06/18 |
| Last modified on | 2019/12/19 17:12:13 |
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Basic information
Public title
The effects of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise
Acronym
The effects of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise
Scientific Title
The effects of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise
Scientific Title:Acronym
The effects of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral nattokinase intake on blood fibrinolysis, coagulation and inflammatory profile during exercise in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood fibrinolysis (48 hours after intake)
Key secondary outcomes
1) blood coagulation
2) inflammatory
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
a single dose of 4,000 F.U. nattokinase intake
Interventions/Control_2
a single dose of placebo intake
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females between 20 and 65 years old
2) Subjects who understand purpose and details of the study and provide written informed consent.
Key exclusion criteria
1) Subjects who have a history of hematologic disease and symptoms of venous or arterial diseases.
2) Subjects being medicated
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Hamaoka |
Organization
Tokyo Medical University
Division name
Sports Medicine for Health Promotion
Zip code
1608402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL
03-3351-6141
hamaoka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kurosawa |
Organization
Tokyo Medical University
Division name
Sports Medicine for Health Promotion
Zip code
1608402
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
TEL
03-3351-6141
Homepage URL
kurosawa@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Sports Medicine for Health Promotion, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Bio Science Laboratory
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo Japan
Tel
0333516141
d-somu@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031710
