UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022002 |
|---|---|
| Receipt number | 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 16:59:59 |
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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
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/
zuka@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Prefecture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025355
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
