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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029231
Receipt No. R000033411
Scientific Title A study of the effect of habitual fluid intake on human health
Date of disclosure of the study information 2017/09/23
Last modified on 2018/03/26

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Basic information
Public title A study of the effect of habitual fluid intake on human health
Acronym A study of the effect of habitual fluid intake on human health
Scientific Title A study of the effect of habitual fluid intake on human health
Scientific Title:Acronym A study of the effect of habitual fluid intake on human health
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the relationship between fluid intake and blood test and urine test.
Basic objectives2 Others
Basic objectives -Others Conformation of the relationship between fluid intake and blood test and urine test.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood test and Urine test on circadian variation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Control of the amount of water intake for 24 hours (Low)
Interventions/Control_2 Control of the amount of water intake for 24 hours (High)
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
Key inclusion criteria (1) From 20 to 65 years healthy males at the time of consent.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subject who are receiving continuous medical treatment.
(2) Subjects with more than one disease in heart, liver, kidney, circulatory organ, and/or diabetes).
(3) Subjects who experienced unpleasant feeling during drawing blood.
(4) Subjects who have been determined ineligible by principal investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiji Watanabe
Organization Suntory global innovation center limited.
Division name Institute for water science
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-0574
Email Reiji_Watanabe@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiji Watanabe
Organization Suntory global innovation center limited.
Division name Institute for water science
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-0574
Homepage URL
Email Reiji_Watanabe@suntory.co.jp

Sponsor
Institute Clinical Support Corporation
Institute
Department

Funding Source
Organization Suntory global innovation center limited.
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
Address
Tel
Email

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 09 Month 23 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 23 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 09 Month 21 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033411

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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