UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046874 |
|---|---|
| Receipt number | R000053455 |
| 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 |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2022/02/09 14:15:57 |
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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
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
UNIVERSITY OF YAMANASHI
Graduate School Department of Interdisciplinary Research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053455
