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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016817
Receipt No. R000019524
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.
Date of disclosure of the study information 2015/03/17
Last modified on 2015/07/01

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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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