UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016817 |
|---|---|
| Receipt number | 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 10:17:05 |
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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
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
npolsinlsin@lsin.org
Sponsor or person
Institute
Linking Setouchi Innate immune Network
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019524
