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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039548
Receipt No. R000045100
Scientific Title Effect of single dose of test food (2019-05) on vascular function (preliminary study)
Date of disclosure of the study information 2020/02/25
Last modified on 2020/12/17

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Basic information
Public title Effect of single dose of test food (2019-05) on vascular function (preliminary study)
Acronym Effect of single dose of test food (2019-05) on vascular function
Scientific Title Effect of single dose of test food (2019-05) on vascular function (preliminary study)
Scientific Title:Acronym Effect of single dose of test food (2019-05) on vascular function
Region
Japan

Condition
Condition Healthy Japanease adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of single dose of test food (2019-05) on vascular function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vascular function after single ingestion of test food
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single dose of test food
Interventions/Control_2
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
64 years-old >=
Gender Male
Key inclusion criteria 1)Healthy Japanease man
2)Employees at the Hayashibara CO.,LTD.
3)Subjects who signed the informed consent for participation in the study
Key exclusion criteria Subjects who judged as unsuitable for this study by the principal investigator for any reasons
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Morishita
Organization Hayashibara CO., LTD.
Division name R&D Division, Development Unit
Zip code 7028002
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Email naoki.morishita@hb.nagase.co.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Morishita
Organization Hayashibara CO., LTD.
Division name R&D Division, Development Unit
Zip code 7028002
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Homepage URL
Email naoki.morishita@hb.nagase.co.jp

Sponsor
Institute Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Hayashibara Co., Ltd.
Address 675-1, Fujisaki, Naka-ku, Okayama
Tel 086-276-3141
Email HB96301@hb.nagase.co.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
2020 Year 02 Month 25 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 15
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
2020 Year 02 Month 05 Day
Date of IRB
2020 Year 02 Month 05 Day
Anticipated trial start date
2020 Year 02 Month 25 Day
Last follow-up date
2020 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
2020 Year 02 Month 20 Day
Last modified on
2020 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045100

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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