UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029322 |
|---|---|
| Receipt number | 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 09:27:09 |
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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
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
hirotar@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032732
