UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of hydrogen-rich water on the level of reactive oxygen species in healthy volunteer
Title of the study (Brief title)	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	Narufumi Suganuma
Organization	Kochi Medical School
Division name	Department of Environmental Medicine
Address	Kohasu, Oko, Nankoku, Kochi 783-8505, Japan.
TEL	81888802407
Email	nsuganuma@kochi-u.ac.jp

Public contact
Name of contact person	Ryoji HIROTA
Organization	Kochi Medical School
Division name	Department of Environmental Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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