UMIN-CTR Clinical Trial

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
Email	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
Email	ygoto@jph-ri.or.jp

Sponsor
Institute	Japan Health & Research Institute
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044897