UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031629 |
|---|---|
| Receipt number | R000036104 |
| Scientific Title | Study for anti-fatigue effects of electrolyzed water : single intake study |
| Date of disclosure of the study information | 2018/03/07 |
| Last modified on | 2018/03/07 16:47:48 |
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Basic information
Public title
Study for anti-fatigue effects of electrolyzed water : single intake study
Acronym
Study for anti-fatigue effects of
electrolized water
Scientific Title
Study for anti-fatigue effects of electrolyzed water : single intake study
Scientific Title:Acronym
Study for anti-fatigue effects of
electrolized water
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-fatigue effect including altertaions of biomarkers related to fatigue by taking electrolized water
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarkers related to fatigue or inflammation
Key secondary outcomes
Subjective fatigue level
Autonomic nervous system
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Ingestion of test water for single time
Interventions/Control_2
Ingestion of placebo water for single time
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy persons aged from 20 to 64 years
Key exclusion criteria
1. Persons who are in treatment
2. Persons who have medical history of circulatory system disease
3. Persons who have disorders of autonomic nervous system
4. Persons have medical history of nervous system disease sucha s unconsciousness, coma, and convulsion, and so on.
6. Persons who have food allergy.
7. Persons who are heavy user of alcohol.
8. Persons whose BMI is less 17 or over 31.
9. Persons who usually take hydrogen-rich water.
10. Persons who have medical history of diabetes, hepathopathy, kidney disease, and heart disease.
11. Persons who participate in another clinical study in one month before giving informed consent of the present study or are now participating in another clinical study.
12. Persons who are judged not suitable to participate in this trial by researchers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunobu Okazaki |
Organization
Osaka City University
Division name
Center for Health Science Innovation
Zip code
Address
9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan
TEL
06-6845-0288
chsi-b@ado.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunobu Okazaki |
Organization
Osaka City University
Division name
Center for Health Science Innovation
Zip code
Address
Knowledge Capital, Grand Front Osaka, 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan
TEL
06-6845-0288
Homepage URL
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Center for Health Science Innovation
RIKEN
Institute
Department
Personal name
Funding Source
Organization
NIHON TRIM CO., LTD.
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
YES
Study ID_1
Kobe 2 2017-06
Org. issuing International ID_1
RIKEN
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪市立大学 健康科学イノベーションセンター(大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 07 | 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
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | 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
| 2018 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036104
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
