UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015045
Receipt number 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 09:09:37

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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 or person

Institute

Keio University

Institute

Department

Personal name



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

Value
https://center6.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