UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effects on reduction of exercise-induced oxidative stress of single ingestion and ingestion timing of hydrogen-dissolved alkaline electrolyzed water(AEW)
Acronym	A study on the effects on reduction of exercise-induced oxidative stress of single ingestion and ingestion timing of hydrogen-dissolved alkaline electrolyzed water
Scientific Title	A study on the effects on reduction of exercise-induced oxidative stress of single ingestion and ingestion timing of hydrogen-dissolved alkaline electrolyzed water
Scientific Title:Acronym	Evaluation of antioxidant effect by drinking alkaline electrolyzed water
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Drinking AEW before or after running exercise at 70% HR max using a treadmill, and analyzing urine and blood before and after exercise to analyze changes in oxidative stress markers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Drink AEW before and after exercise. Urine will be collected before and after exercise and analyzed for oxidative stress markers. (HEL, MDA, 8OHdG)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Drinking the test water by groups. Control group: drinking purified water
Interventions/Control_2	Drinking the test water by groups. Control group: drinking AEW
Interventions/Control_3	Drinking the test water by groups. Control group: drinking highly hydrogen dissolved AEW
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	23 years-old >=
Gender	Male
Key inclusion criteria	The subjects were 18 healthy men
Key exclusion criteria	Exclude smokers, those who routinely take antioxidants, or those who routinely drink alkaline electrolyzed water
Target sample size	18

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	UNIVERSITY OF YAMANASHI Graduate School Department of Interdisciplinary Research
Institute
Department

Funding Source
Organization	Panasonic Corporation, Appliances Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	H20-13
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	2022 Year 03 Month 01 Day

Related information
URL releasing protocol	https://togodb.biosciencedbc.jp/togodb/show/yokou_abstract/200907636320535
Publication of results	Partially published

Result
URL related to results and publications	https://togodb.biosciencedbc.jp/togodb/show/yokou_abstract/200907636320535
Number of participants that the trial has enrolled	18
Results	Single intake of highly hydrogen-dissolved alkaline ionized water may suppress oxidative stress-induced cell damage
Results date posted	2022 Year 02 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy male university students (n = 18) were used as subjects.
Participant flow	Participants were randomly divided into three groups: a normal water drinking group (PW group), an alkaline ionized water drinking group (AEW group), and a highly hydrogen-dissolved alkaline ionized water drinking group (HAEW group). Each group drank 500 ml of the prescribed water after the exercise.
Adverse events	No report.
Outcome measures	Determination of malondialdehyde (MDA) concentration and urinary excretion of 8-OHdG, a marker of oxidative stress
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 08 Day
Date of IRB	2008 Year 11 Month 19 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2009 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2022 Year 02 Month 09 Day
Last modified on	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053455