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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033587
Receipt No. R000038303
Official scientific title of the study A study of the effect of fluid intake (SIC-2018-04-WKNK)
Date of disclosure of the study information 2018/08/04
Last modified on 2018/08/01

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Basic information
Official scientific title of the study A study of the effect of fluid intake (SIC-2018-04-WKNK)
Title of the study (Brief title) A study of the effect of fluid intake (SIC-2018-04-WKNK)
Region
Japan

Condition
Condition No applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of fluid intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fasting plasma glucose concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Additional water intake for twelve weeks
Interventions/Control_2 No intervention
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
50 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria (1) From 50 to 75 years Japanese at the time of consent.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who are under treatment, medication and life-style advice for diabetes and hypertention by doctors.
(2) Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine and metabolic disorders and/or affected with an infectious disease which is required to report to the authorities.
(3) Subjects who experienced unpleasant feeling during drawing blood.
(4) Subjects who have been determined ineligible by principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator Hiroshi Watanabe
Organization Suntory global innovation center limited.
Division name Research Institute
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-0593
Email H_Watanabe@suntory.co.jp

Public contact
Name of contact person Yumi Nakamura
Organization Suntory global innovation center limited.
Division name Research Institute
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL 050-3182-2513
Homepage URL
Email Yumi_Nakamura@suntory.co.jp

Sponsor
Institute Hokkaido Information University
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)

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 08 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 23 Day
Anticipated trial start date
2018 Year 08 Month 04 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 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038303

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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