UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025517 |
|---|---|
| Receipt number | 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 16:53:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hirotar@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029372
