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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033336
Receipt No. R000038005
Official scientific title of the study Improvement of blood pressure and blood flow by intake of test article
Date of disclosure of the study information 2018/07/11
Last modified on 2018/07/09

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Basic information
Official scientific title of the study Improvement of blood pressure and blood flow by intake of test article
Title of the study (Brief title) Improvement of blood pressure and blood flow by intake of test article
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate blood pressure and blood flow effect due to ingestion of specimens of subjects whose blood pressure and peripheral blood temperature tend to be low
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, blood flow, body surface temperature, VAS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 Treatment
Type of intervention
Food
Interventions/Control_1 4 test foods intake per day for 12 weeks
Interventions/Control_2 4 placebo foods intake per day for 12 weeks
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
18 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria Subjects with low blood pressure (systolic blood pressure 100 mm Hg or more, diastolic blood pressure 60 mm Hg or more) at normal blood pressure (120 mmHg or less, or 80 mmHg or less)
Key exclusion criteria 1. Subjects who tend to have high blood pressure
2.Subjects with food allergies
3. Subjects who are pregnant or lactating
4. Subjects who consume medicinal product which may influence the outcome of the study
5.Subjects who consume food which may influence the outcome of the study
6. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size 54

Research contact person
Name of lead principal investigator Masatomo Najima
Organization Japan clinical trial association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial association
Institute
Department

Funding Source
Organization Realnet Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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
2018 Year 07 Month 11 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 14 Day
Anticipated trial start date
2018 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 09 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038005

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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