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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022002
Receipt No. R000025355
Scientific Title Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Date of disclosure of the study information 2016/04/21
Last modified on 2016/04/20

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Basic information
Public title Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Acronym Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Scientific Title Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Scientific Title:Acronym Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this clinical study is to investigate the effect of refined deepsea water taken form Muroto off-shore in Kochi on the human gut immunity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparative analyses between two groups (refined deepsea water vs. control water): Endpoints; changes of intestinal microbiota, decomposed matters and secretary IgA in feces, and equol in urine.
Key secondary outcomes Improvement effect of symptoms including intestinal function.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of refined deepsea water (Hardness 1000) for 12 weeks (1L/1Day)
Interventions/Control_2 Ingestion of mineral water for 12 weeks (1L/1Day)
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 (20 years-old <=)
Key exclusion criteria (1) Subject who are under treatment or have a history of needing medical treatment.
(2) Subjects who plan to go overseas more than one week during study period.
(3) Subjects who routinely drink refined deepsea water.
(4) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(5) Subjects who are judged as unsuitable for the study by physician for any other reasons.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Takeuchi
Organization Kochi Medical School
Division name Clinical Laboratory Medicine
Zip code
Address Kohasu, Oko-cho, Nankoku-city, 783-8505, Japan
TEL 088-880-2427
Email htake@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ishizuka
Organization Kochi University
Division name Center for Regional Collaboration (CRC)
Zip code
Address Asakura-Honmachi, Kochi 780-8073, Japan
TEL 088-844-8555
Homepage URL http://www.kochi-senpro.jp/
Email zuka@kochi-u.ac.jp

Sponsor
Institute Kochi Prefecture
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 04 Month 21 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
2015 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 05 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
2016 Year 04 Month 20 Day
Last modified on
2016 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025355

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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