UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of rich-hydrogen water drinking to gut peptide
Title of the study (Brief title)	The effect of rich-hydrogen water drinking to gut peptide
Region	Japan

Condition
Condition	Parkinson's disease, healthy control
Classification by specialty	Medicine in general Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analysis the hemodynamic changes after drinking rich hydrogen water
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	the hemodynamic changes of gut peptide and inflammatory marker
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	hydrogen water
Interventions/Control_2	natural water
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	gut peptide
Key exclusion criteria	diabetes mellitus
Target sample size	40

Research contact person
Name of lead principal investigator	Masaaki Hirayama
Organization	Nagoya graduate school of medicine university
Division name	department of clinical laboratory science
Address	1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, Aichi
TEL	052-719-1184
Email	hirasan@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masaaki Hirayama
Organization	Nagoya graduate school of medicine university
Division name	department of clinical laboratory science
Address	1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, Aichi
TEL	052-719-1184
Homepage URL
Email	hirasan@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya graduate school of medicine university
Institute
Department

Funding Source
Organization	Nagoya graduate school of medicine university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 11 Month 05 Day
Anticipated trial start date	2015 Year 11 Month 06 Day
Last follow-up date	2016 Year 11 Month 01 Day
Date of closure to data entry	2016 Year 11 Month 01 Day
Date trial data considered complete	2016 Year 11 Month 06 Day
Date analysis concluded	2016 Year 11 Month 06 Day

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

Management information
Registered date	2015 Year 11 Month 05 Day
Last modified on	2017 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017291