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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034161
Receipt No. R000038944
Scientific Title Effects of electrolyzed water on attenuating fatigue induced by cognitive task
Date of disclosure of the study information 2018/10/22
Last modified on 2019/03/18

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Basic information
Public title Effects of electrolyzed water on attenuating fatigue induced by cognitive task
Acronym Effects of electrolyzed water on attenuating fatigue induced by cognitive task
Scientific Title Effects of electrolyzed water on attenuating fatigue induced by cognitive task
Scientific Title:Acronym Effects of electrolyzed water on attenuating fatigue induced by cognitive task
Region
Japan

Condition
Condition Helathy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of electrolized water on attenuating fatigue induced by cognitive task
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biomarkers related to fatigue and inflammation
Key secondary outcomes Performance level of Cognitive task
Subjective fatigue level
Autonomic nervous system

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of test water for single time
Interventions/Control_2 Ingestion of placebo water for single time
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
65 years-old >
Gender Male and Female
Key inclusion criteria Healthy persons aged from 20 to 64 years
Key exclusion criteria 1. Persons who are in treatment
2. Persons who have medical history of
circulatory system disease
3. Persons who have disorders of
autonomic nervous system
4. Persons who have medical history of
nervous system disease such as unconsciousness, coma, and convulsion, and so on
5. Persons who have sleep disorder
6. Persons who have food allergy
7. persons who are heavy user of alcohol
8. Persons whose BMI is less 17 or over 31
9. Persons who usually take hydrogen-
rich water
10. Persons who have medical history of
diabetes, hepathopathy, kidney disease, and heart disease
11. Persons who participate in another
clinical study in one month before giving informed consent of the present study or are now participating in another clinical
study
12. Persons who are or may be pregnant,
or nursing
13. Persons who smoke
14. Persons who engage in night shift work
15. Persons who are judged not suitable
to participate inthis trial by researchers
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization RIKEN Center for Biosystems Dynamics Research (BDR) /Osaka City University
Division name Laboratory for Pathophysiological and Health Science /Center for Health Science Innovation
Zip code
Address 6-7-3 Minatojima minamimachi, Chuo-ku, Kobe
TEL 06-6845-0288
Email yywata@riken.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunobu Okazaki
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address Knowledge Capital, Grand Front Osaka, 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan
TEL 06-6845-0288
Homepage URL
Email chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute RIKEN Center for Biosystems Dynamics Research (BDR) /Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization NIHON TRIM CO., LTD.
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 Kobe 2 2017-06
Org. issuing International ID_1 RIKEN
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学 健康科学イノベーションセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 22 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
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
2018 Year 07 Month 20 Day
Date of IRB
2018 Year 07 Month 23 Day
Anticipated trial start date
2018 Year 09 Month 07 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 15 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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