UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.
Title of the study (Brief title)	Efficacy of drinking hydrogen water on exercise tolerance and fatigue.
Region	Japan

Condition
Condition	Health care for healthy adults with no illness
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate whether healthy adults improve exercise tolerance and/or reduce fatigue by drinking hydrogen water.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	After drinking 500 mL placebo or hydrogen water, maximum oxygen consumption and a conscious fatigue degree of volunteers are measured by bicycle-exercise with an ergometer. The maximum oxygen consumption is examined by gradually raising the load of the pedal, and monitoring a change of the heart beat pulse and normalized by age, body weight. The conscious fatigue degree is reported according to the Borg index and a visual analog scale (VAS).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Volunteers drink 500 mL placebo water to obtain background data.
Interventions/Control_2	After 2 weeks, half of them drink 500 mL of placebo and half drink hydrogen water to obtain data.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults with no illness who dose not drink hydrogen water for most recent three months.
Key exclusion criteria	Just before examination, if body temperature or blood pressure exceeds 37 degree or 141 mmHg, we will exclude him from the subjects.
Target sample size	100

Research contact person
Name of lead principal investigator	Toshio Mikami
Organization	Nippon Medical School
Division name	Department of Health and Sports Science
Address	Department of Health and Sports Science, Nippon Medical School, 1-7-1 Kyounan-cho, Musashino, Tokyo 180-0023, Japan
TEL	0422-34-3451
Email	mikami@nms.ac.jp

Public contact
Name of contact person	Toshio Mikami
Organization	Nippon Medical School
Division name	Department of Health and Sports Science
Address	Department of Health and Sports Science, Nippon Medical School, 1-7-1 Kyounan-cho, Musashino, Tokyo
TEL	0422-34-3451
Homepage URL
Email	mikami@nms.ac.jp

Sponsor
Institute	Department of Health and Sports Science, Nippon Medical School
Institute
Department

Funding Source
Organization	Hydrogen water consortium
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 06 Day
Anticipated trial start date	2017 Year 09 Month 11 Day
Last follow-up date
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	2017 Year 09 Month 08 Day
Last modified on	2017 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033221