UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029062 |
|---|---|
| Receipt number | 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 17:16:04 |
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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
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
mikami@nms.ac.jp
Sponsor or person
Institute
Department of Health and Sports Science, Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033221
