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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029321
Receipt No. R000033514
Scientific Title Evaluation of electrolyzed hydrogen water to metabolic syndrome patients in Susaki city- Double blind clinical trial
Date of disclosure of the study information 2017/09/28
Last modified on 2017/11/20

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Basic information
Public title Evaluation of electrolyzed hydrogen water to metabolic syndrome patients in Susaki city- Double blind clinical trial
Acronym Evaluation of hydrogen rich water.
Scientific Title Evaluation of electrolyzed hydrogen water to metabolic syndrome patients in Susaki city- Double blind clinical trial
Scientific Title:Acronym Evaluation of hydrogen rich water.
Region
Japan

Condition
Condition metabolic syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Oxidative stress is implicated in the pathogenesis of various disorders, from age-related cognitive decline and lifestyle-related diseases to cancers; and, in recent years, electrolyzed hydrogen water has been studied for its anti-oxidant properties in clinical trials. However, no human study yet has examined whether a long-term intake of EHW could improve metabolic syndrome. We evaluate the effects of a long-term intake of EHW on metabolic syndrome in Susaki city.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing abdominal Circumstance from baseline
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Drink EH water daily 350 mL 3 times per day for 3 months.
Interventions/Control_2 Drink Placebo water daily 350 mL 3 times per day for 3 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Persons who are 30 years of age or older who have a resident card and residence in Susaki City and who can install a hydrogen water conditioner (test water conditioner)
2.One who was diagnosed as either 1) or 2)
1) Metabolic syndrome group (from the examination meeting of the Ministry of Health, Labor and Welfare Study meeting) Abdominal girth (male 85 cm or more, female 90 cm or more) plus two or more of the following items
A: sugar metabolism (fasting blood glucose 110 mg / dL or more)
b: Lipid (neutral fat 150 mg / dL or more or HDL-C 40 mg / dL or less)
C: Blood pressure (at least 130 mmHg in systole and / or at least 85 mmHg in diastole)
If you are receiving medication for high TG, low HDL-C, hypertension, diabetes, each item
To
2) Metabolic Syndrome Preliminary Group (From the results of the study meeting of the Ministry of Health, Labor and Welfare)
D: Abdominal girth (male 85 cm or more, female 90 cm or more) Persons whose sugar metabolism, lipid, blood pressure abnormality is up to one item
E: Abdominal circumference is not more than the reference value reference value, but those who have BMI 25 or more and have one or more of the above risks
Include in each item if you are receiving medication for high TG, low HDL-C, high blood pressure, diabetes.
Key exclusion criteria 1.Person who has judged that doctor is ineligible for participation 1) Heart disease Persons with chronic kidney disease 2) A person with a disease accompanied by weight loss (thyroid hyperthyroidism etc.) 3) There are severe diseases or malignant tumors etc. Person who installed a hydrogen water server 3 Person who is not gaining consent Rationale For setting 1, consideration is given to the safety of the research subjects For. 3) Malignant tumor: When five years have elapsed after completion of recovery, it can be incorporated. 2 In order to influence the main evaluation items.
Target sample size 200

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 088-880-2407
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 088-880-2407
Homepage URL
Email ryoryo2003@yahoo.co.jp

Sponsor
Institute Department of Preventive Medicine,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 高陵病院(高知県須崎市)、須崎くろしお病院(高知県須崎市)

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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 04 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 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033514

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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