UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of hydrogen rich water to pre metabolic syndrome participants
Title of the study (Brief title)	Evaluation of hydrogen rich water to pre metabolic syndrome participants
Region	Japan

Condition
Condition	Pre-metabolic syndrome
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate that long-term intaking a hydrogen rich water improve pre-metabolic syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Size of abdominal circumference at 3 month after taking hydrogen rich water
Key secondary outcomes	Fasting blood glucose level, HbA1c, triglyceride, HDL-c, blood pressure, 8-OHdG, 8 isoprostane, MCP-1, SOD, adiponectin, frequency of food intake questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	(a) Hydrogen rich water group Participants should drink a test water 1050ml everyday for 3 month.
Interventions/Control_2	(b) Tap water group Participants should drink a test water 1050ml everyday for 3 month.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Pre Metabolic syndrome criteria
Key exclusion criteria	Heart Disease, chronic kidney disease and severe other disease
Target sample size	30

Research contact person
Name of lead principal investigator	Narufumi Suganuma
Organization	Kochi University
Division name	Department of Preventive Medicine
Address	Kohasu, Oko, Nankoku, Kochi, Japan
TEL	0888802407
Email	nsuganuma@kochi-u.ac.jp

Public contact
Name of contact person	Ryoji Hirota
Organization	Kochi University
Division name	Department of Preventive Medicine
Address	Kohasu, Oko, Nankoku, Kochi, Japan
TEL	0888802407
Homepage URL
Email	hirotar@kochi-u.ac.jp

Sponsor
Institute	Kochi University
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
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	2017 Year 09 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 09 Month 28 Day
Last modified on	2017 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032732