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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029322
Receipt No. R000032732
Scientific Title Evaluation of hydrogen rich water to pre metabolic syndrome participants
Date of disclosure of the study information 2017/09/28
Last modified on 2017/09/28

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Basic information
Public title Evaluation of hydrogen rich water to pre metabolic syndrome participants
Acronym Evaluation of hydrogen rich water to pre metabolic syndrome participants
Scientific Title Evaluation of hydrogen rich water to pre metabolic syndrome participants
Scientific Title:Acronym 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
1st name
Middle name
Last name Narufumi Suganuma
Organization Kochi University
Division name Department of Preventive Medicine
Zip code
Address Kohasu, Oko, Nankoku, Kochi, Japan
TEL 0888802407
Email nsuganuma@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoji Hirota
Organization Kochi University
Division name Department of Preventive Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
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

Other
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

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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