UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039380 |
|---|---|
| Receipt number | R000044897 |
| Scientific Title | A research of the effect of mineral water consumption derived from Kaneyama Daikokuyu hot spring |
| Date of disclosure of the study information | 2020/02/04 |
| Last modified on | 2020/02/03 12:23:34 |
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Basic information
Public title
A research of the effect of mineral water consumption derived from Kaneyama Daikokuyu hot spring
Acronym
A research of the effect of Kaneyama Daikokuyu consumption
Scientific Title
A research of the effect of mineral water consumption derived from Kaneyama Daikokuyu hot spring
Scientific Title:Acronym
A research of the effect of Kaneyama Daikokuyu consumption
Region
| Japan |
Condition
Condition
Lifestyle disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of mineral water consumption derived from Kaneyama Daikokuyu hot spring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical blood test (HbA1c, glycoalbumin, blood glucose, insulin, AST, ALT, ganma GTP, Na, Cl, Mg, Ca, Cortisol, Number of Red Blood Cells, Hb, Ht, Number of Red Blood Cells, ALP, Total-Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Neutral Fat, Creatinine, eGFR, Uric Acid)
Key secondary outcomes
Gastrointestinal Symptom Rating Scale (GSRS), Japanese edition
Questionnaire
Body weight
Body Mass Index (BMI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of mineral water that collected from Daikokuyu hot spring for 14 days. Consumption of 500 ml of mineral water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner).
Interventions/Control_2
Consumption of Stock pile water (Hardness 0) for 14 days. Consumption of 500 ml of tap water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner).
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
Healthy Adults
Key exclusion criteria
Patients of Diabetes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Goto |
Organization
Japan Health & Research Institute
Division name
Research Division
Zip code
103-0027
Address
3-1-4, Nihonbashi, Chuo-ku Tokyo, Japan
TEL
+81-3-5290-1621
ygoto@jph-ri.or.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Goto |
Organization
Japan Health & Research Institute
Division name
Research Division
Zip code
103-0027
Address
3-1-4, Nihonbashi, Chuo-ku Tokyo, Japan
TEL
+81-3-5290-1621
Homepage URL
ygoto@jph-ri.or.jp
Sponsor or person
Institute
Japan Health & Research Institute
Institute
Department
Personal name
Funding Source
Organization
Kaneyama Town
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute
Address
3-1-4, Nihonbashi, Chuo-ku Tokyo, Japan
Tel
+81-3-5290-1621
ygoto@jph-ri.or.jp
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
| 2020 | Year | 02 | Month | 04 | 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
30
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044897
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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