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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024514
Receipt No. R000028216
Scientific Title A study of the effect of fluid intake on human health.
Date of disclosure of the study information 2016/10/24
Last modified on 2018/03/26

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Basic information
Public title A study of the effect of fluid intake on human health.
Acronym A study of the effect of fluid intake on human health.
Scientific Title A study of the effect of fluid intake on human health.
Scientific Title:Acronym A study of the effect of 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 effect of fluid intake on human health.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood test, Urine test, Subjective test at the start point (day 0) and the end point (day 14) of intervention, and at the end point of recovery phase (day 28)
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 Additional fluid intake for two weeks
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
30 years-old >
Gender Male
Key inclusion criteria (1) Twenty-something 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 12

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 Suntory global innovation center limited.
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
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
2016 Year 10 Month 24 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
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 24 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
2016 Year 10 Month 21 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028216

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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