UMIN-CTR Clinical Trial

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
Email	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
Email	m.kiuchi1986@gmail.com

Sponsor
Institute	Panasonic Corporation, Appliances Company Corporate Engineering Division, HA Development Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043623