UMIN-CTR Clinical Trial

Basic information
Public title	Study for anti-fatigue effects of electrolyzed water : single intake study
Acronym	Study for anti-fatigue effects of electrolized water
Scientific Title	Study for anti-fatigue effects of electrolyzed water : single intake study
Scientific Title:Acronym	Study for anti-fatigue effects of electrolized water
Region	Japan

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

Objectives
Narrative objectives1	To investigate the anti-fatigue effect including altertaions of biomarkers related to fatigue by taking electrolized water
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biomarkers related to fatigue or inflammation
Key secondary outcomes	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 have medical history of nervous system disease sucha s unconsciousness, coma, and convulsion, and so on. 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 judged not suitable to participate in this trial by researchers.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazunobu Okazaki
Organization	Osaka City University
Division name	Center for Health Science Innovation
Zip code
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan
TEL	06-6845-0288
Email	chsi-b@ado.osaka-cu.ac.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	Osaka City University, Center for Health Science Innovation RIKEN
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 03 Month 07 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	2017 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 07 Day
Last modified on	2018 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036104

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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