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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027685
Receipt No. 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 2019/06/14

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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
Email 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
Email kurosawa@tokyo-med.ac.jp

Sponsor
Institute Department of Sports Medicine for Health Promotion, Tokyo Medical University
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 18 Day
Last follow-up date
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 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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