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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015045
Receipt No. R000017497
Scientific Title Effects of hot spring water drinking and/or bathing on the human physiological homeostasis
Date of disclosure of the study information 2014/09/03
Last modified on 2014/09/04

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Basic information
Public title Effects of hot spring water drinking and/or bathing on the human physiological homeostasis
Acronym ONSEN - Metabolome
Scientific Title Effects of hot spring water drinking and/or bathing on the human physiological homeostasis
Scientific Title:Acronym ONSEN - Metabolome
Region
Japan Asia(except Japan)

Condition
Condition Medicine in general
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Endocrinology and Metabolism Nephrology Psychosomatic Internal Medicine
Geriatrics Gastrointestinal surgery Dermatology
Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of hot spring water drinking and/or bathing to human
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Metabolome analysis of plasma, urine and feces
Gut microbiome analysis
Subjective status (Visual Analog Scale)
Gastrointestinal Symptom Rating Scale
Mood Check List - Short Form
Key secondary outcomes Weight
Blood pressure
Waist size
Blood test (urinary acid, blood glucose in serum, glycoalbumin, insulin, NaCl, Ca, Mg, cortisol, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, blood glucose in plasma (morning fasting sample), HOMA-R(morning fasting sample))

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Drinking and/or bathing hot spring water
Interventions/Control_2
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 Who does not drink and/or bathe hot spring water in daily
Key exclusion criteria Who have habit drink and/or bathe hot spring water in daily
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Fukuda
Organization Keio University
Division name Institute for Advanced Biosciences
Zip code
Address Mizukami, Kakuganji, Tsuruoka City, Yamagata
TEL +81-235-29-0528
Email sfukuda@sfc.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinnosuke Murakami
Organization Keio University
Division name Institute for Advanced Biosciences
Zip code
Address 246-2
TEL +81-235-29-0528
Homepage URL
Email mushin@sfc.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Japan health and research institute
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 09 Month 03 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 03 Day
Last modified on
2014 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017497

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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