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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025517
Receipt No. R000029372
Scientific Title Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Date of disclosure of the study information 2017/01/06
Last modified on 2017/01/04

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Basic information
Public title Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Acronym Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Scientific Title Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Scientific Title:Acronym Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate reducing a reactive oxygen spicies after drinking hydrogen water, we will conduct this clinical study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Reactive Oxygen Metabolites Biological Anti-oxidant Potential in plasma
Key secondary outcomes Measure the Level of 8-OHdG and 8-isoprostane, BAP, dROMs in plasma and ask food frequency questionnaire.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Participants should intake of hydrogen-rich water, tap water or hydrogen water. Amount of 500 ml of water they need drink. Total 3 days they should drink water for this study.
Interventions/Control_2 Participants should intake of hydrogen-rich water, tap water or hydrogen water. Amount of 350 ml of water they need drink. Total 3 days they should drink water for this study.
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
30 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Participants do not have a current medical history
Key exclusion criteria 1.person who cannot maintain rest during research
2.Smoker
3.Persons with BMI 19 or less
4.Person who is continuous drinking Trim electrolytic hydrogen water
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narufumi Suganuma
Organization Kochi Medical School
Division name Department of Environmental Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 81888802407
Email nsuganuma@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoji HIROTA
Organization Kochi Medical School
Division name Department of Environmental Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL 81888802407
Homepage URL
Email hirotar@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
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 NIHON TRIM CO.,LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1 28-90
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 高知大学医学部環境医学教室

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 06 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
2016 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
2017 Year 01 Month 27 Day
Date of closure to data entry
2017 Year 03 Month 10 Day
Date trial data considered complete
2017 Year 03 Month 25 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029372

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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