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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031800
Receipt No. R000036290
Scientific Title The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Date of disclosure of the study information 2018/03/22
Last modified on 2018/04/26

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Basic information
Public title The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Acronym The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Scientific Title The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Scientific Title:Acronym The effect of daily drinking of alkaline electrolyzed water (AEW) on health
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of daily drinking of alkaline electrolyzed water (AEW) on health, including gastrointestinal symptoms, when a person without abdominal indefinite complaint.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Before the experiment and after the four-week period of every day water drinking, Blood tests, physical fitness evaluations, and questionnaire evaluations is conducted.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Device,equipment
Interventions/Control_1 Four-week period of every day water drinking,
PW drinking group: drink purified tap water

Interventions/Control_2 Four-week period of every day water drinking,
AEW drinking group : drink alkaline electrolyzed water which made by electrolysis of purified tap water
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
70 years-old >
Gender Male and Female
Key inclusion criteria Healthy men and women (20's-60's) medical checkup examinees who visited the Osaka City Citizen Health Development Consultation Center were used as test subjects
Key exclusion criteria 1) If there is a request of the drinking water stop from the subject or the person who has the consent on behalf of the subject
2) If the subject is no longer consulted on the way (we follow up as much as possible about the reasons for no visit.)
3) In addition, if the doctor has determined that the inappropriate continuation of the test
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Nakamura
Organization Osaka City University Graduate School of Medicine
Division name Medical informatics & Medical Economics
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3788
Email nhajime@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Tanaka
Organization Panasonic Corporation, Appliances Company
Division name Corporate Engineering Division, HA Development Center
Zip code
Address 2-3-1-2 Noji-higashi, Kusatsu Japan
TEL 050-3687-9658
Homepage URL
Email tanaka.yoshinori@jp.panasonic.com

Sponsor
Institute Matsushita Electric Works Co., Ltd.
Home Appliances R&D Center
Institute
Department

Funding Source
Organization Matsushita Electric Works Co., Ltd.
Home Appliances R&D Center
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 837
Org. issuing International ID_1 ethics committee of Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市環境保健協会市民健康づくり相談センター

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2005 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 25 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
2018 Year 03 Month 19 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036290

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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