UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039507 |
|---|---|
| Receipt number | R000043623 |
| Scientific Title | Effects of drinking Alkaline electrolyzed water on gut microbiota profile |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2020/02/17 22:57:18 |
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Basic information
Public title
Effects of drinking Alkaline electrolyzed water on gut microbiota profile
Acronym
Effects of drinking Alkaline electrolyzed water on gut microbiota profile
Scientific Title
Effects of drinking Alkaline electrolyzed water on gut microbiota profile
Scientific Title:Acronym
Effects of drinking Alkaline electrolyzed water on gut microbiota profile
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure the gut microbiota before and after drinking 2 weeks of alkaline electrolyzed water, and verify the mechanism that alleviates gastrointestinal symptoms and changes stool properties.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Human stool is collected with a stool collection kit before and after the 2-week drinking intervention test, and a large amount of sequence analysis is performed using a next-generation sequencer for PCR products amplified 16S rRNA region.
The stool during the test period is evaluated on a Blistall scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
2-week period of every day water drinking,
PW drinking group: drink purified tap water
Interventions/Control_2
2-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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
The subjects were 20 healthy men.
Key exclusion criteria
Exclude smokers, those who routinely take antioxidants, or those who routinely drink alkaline electrolyzed water
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Koyama |
Organization
UNIVERSITY OF YAMANASHI
Division name
Graduate School Department of Interdisciplinary Research
Zip code
400-8510
Address
4-4-37 Takeda, Kofu, Yamanashi
TEL
81-55-220-8202
koyama@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | MASATAKA |
| Middle name | |
| Last name | KIUCHI |
Organization
UNIVERSITY OF YAMANASHI
Division name
Graduate School Department of Interdisciplinary Research
Zip code
400-8510
Address
4-4-37 Takeda, Kofu, Yamanashi
TEL
81-55-220-8202
Homepage URL
m.kiuchi1986@gmail.com
Sponsor or person
Institute
Panasonic Corporation, Appliances Company
Corporate Engineering Division, HA Development Center
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation, Appliances Company
Corporate Engineering Division, HA Development 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
University of Yamanashi, Faculty of Education, Ethics Committee
Address
4-4-37 Takeda, Kofu, Yamanashi
Tel
81-55-252-1111
edu-admin@yamanashi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
H30-25
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山梨大学甲府キャンパス 運動生理・生化学実験室
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 18 | 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
20
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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | 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=R000043623
