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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031629 |
Receipt No. | 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 |
Basic information | ||
Public title | Study for anti-fatigue effects of electrolyzed water : single intake study | |
Acronym | Study for anti-fatigue effects of
electrolized water |
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Scientific Title | Study for anti-fatigue effects of electrolyzed water : single intake study | |
Scientific Title:Acronym | Study for anti-fatigue effects of
electrolized water |
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Region |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka City University, Center for Health Science Innovation
RIKEN |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 | |
Registered date | File name |