UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024514 |
|---|---|
| Receipt number | 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 13:20:12 |
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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
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
Reiji_Watanabe@suntory.co.jp
Sponsor or person
Institute
Suntory global innovation center limited.
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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