UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031800 |
|---|---|
| Receipt number | 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 | 2020/02/17 22:28:06 |
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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
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
tanaka.yoshinori@jp.panasonic.com
Sponsor or person
Institute
Matsushita Electric Works Co., Ltd.
Home Appliances R&D Center
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
http://www.medgasres.com/article.asp?issn=2045-9912;year=2018;volume=8;issue=4;spage=160;epage=166;a
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 09 | Day |
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
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036290
| 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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