UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigation of the effect of refined deepsea water on the human gut immunity.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroaki Takeuchi
Organization	Kochi Medical School
Division name	Clinical Laboratory Medicine
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	Satoshi Ishizuka
Organization	Kochi University
Division name	Center for Regional Collaboration (CRC)
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 04 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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