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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029062
Receipt No. R000033221
Scientific Title Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.
Date of disclosure of the study information 2017/09/11
Last modified on 2017/09/08

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Basic information
Public title Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.
Acronym Efficacy of drinking hydrogen water on exercise tolerance and fatigue.
Scientific Title Efficacy of drinking hydrogen water on exercise tolerance and fatigue accessed by placebo controlled double blinded examination.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshio Mikami
Organization Nippon Medical School
Division name Department of Health and Sports Science
Zip code
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
1st name
Middle name
Last name Toshio Mikami
Organization Nippon Medical School
Division name Department of Health and Sports Science
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 06 Day
Date of IRB
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

Other
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

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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