UMIN-CTR Clinical Trial

Basic information
Public title	Anti-fatigue effect by one week continuous intake of deep-sea-water containing water in the adult males: a randomized cross-over study.
Acronym	Anti-fatigue effect by deep-sea-water containing water.
Scientific Title	Anti-fatigue effect by one week continuous intake of deep-sea-water containing water in the adult males: a randomized cross-over study.
Scientific Title:Acronym	Anti-fatigue effect by deep-sea-water containing water.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the anti-fatigue effect of intake of deep-sea-water containing water in healthy males.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	evaluation of anti-fatigue index (lactic acid, myoglobin, noradrenaline and cortisol in serum). lassitude levels by a visual analog scale (VAS).
Key secondary outcomes	immunological test(serum IL-6). body measurement.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A-Washout-B
Interventions/Control_2	B-Washout-A
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	35 years-old >
Gender	Male
Key inclusion criteria	Key inclusion criteria are as follows. 1) Who can understand its contents, and who can consent to the study participation by receiving the explanation. 2) Healthy men who is less than 35 years old more than 20 years old does not be receiving medical treatment of disease (especially circulator disease) at the time of informed consent.
Key exclusion criteria	Key exclusion criteria are as follows. 1) Who has habit of intake test water or control water. And who has intake mineral water containing more than 0.3mg/100mL of Mg because the average Mg concentration is 0.25mg/100mL in soft water. 2) Who has using drug, food and instrument that are judged unsuitable for this study by principle investigator and subinvestigator. 3) Who is participates in other interventional study or who is planning to participate. 4) Who has donated over 400mL of blood within the last three months of the date of consent or over 200mL of blood within the last one month of the date of consent. 5) Who is judged unsuitable for this study by principle investigator and subinvestigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichiro Miyake, Takeru Nakamoto
Organization	Miyake Medical Institute Group
Division name	medical office
Zip code
Address	1-10-16, Ban-cho, Takamatsu-shi, Kagawa-Ken
TEL	087-831-2101
Email	takeruna@miyake.or.jp

Public contact
Name of contact person	1st name Middle name Last name Sachiko Okatani
Organization	Linking Setouchi Innate immune Network
Division name	Secretariat
Zip code
Address	3rd floor, 2217-16, Hayashi-cho,Takamatsu-shi, Kagawa-Ken
TEL	087-867-9201
Homepage URL
Email	npolsinlsin@lsin.org

Sponsor
Institute	Linking Setouchi Innate immune Network
Institute
Department

Funding Source
Organization	DyDo Takenaka Beverage Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 03 Month 17 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	Completed
Date of protocol fixation	2015 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 17 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	2015 Year 03 Month 17 Day
Last modified on	2015 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019524

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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