UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Experiment for verification of the anti-fatigue effects of hydrogen-rich water in daily life: cross-over study.
Title of the study (Brief title)	The anti-fatigue effects of hydrogen-rich water.
Region	Japan

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

Objectives
Narrative objectives1	Investigation of the anti-fatigue effects of hydrogen-rich water on subjective fatigue and autonomic nervous system in daily life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in subjective fatigue, autonomic nervous function, oxidation stress and antioxidant activity after 4 weeks.
Key secondary outcomes	Amount of activity Cognitive function

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test water for 4 weeks. / Wash out for 4 weeks. / Ingestion of placebo water for 4 weeks.
Interventions/Control_2	Ingestion of placebo water for 4 weeks. / Wash out for 4 weeks. / Ingestion of test water for 4 weeks.
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy persons who are aged from 20 to 49 years. 2.Persons who are not shift worker.
Key exclusion criteria	1.Pregnant women. 2.Persons who are in treatment. 3.Persons who have medical history of cardiovascular disease. 4.Persons who have medical history of nervous system disease such as unconsciousness, coma, and convulsion, etc. 5.Persons who have insomnia. 6.Persons who have food allergy. 7.Persons who are heavy user of alcohol. 8.Persons who are judged not suitable to participate in this trial by investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuyoshi Watanabe
Organization	Osaka City University
Division name	Center for Health Science Innovation
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL	06-6485-0288
Email	chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person	Kei Mizuno
Organization	Osaka City University
Division name	Center for Health Science Innovation
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL	06-6485-0288
Homepage URL
Email	chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization	Melodian Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 06 Day
Anticipated trial start date	2014 Year 09 Month 12 Day
Last follow-up date	2014 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2016 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025795