UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049758 |
|---|---|
| Receipt number | R000056676 |
| Scientific Title | Effects of prolonged intake of functional water in daily life |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2022/12/13 09:47:26 |
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Basic information
Public title
Effects of prolonged intake of functional water in daily life
Acronym
Effects of functional water
Scientific Title
Effects of prolonged intake of functional water in daily life
Scientific Title:Acronym
Effects of prolonged intake of functional water in daily life
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of prolonged intake of functional water on health promotion in daily life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of psychophysiological and biochemical indices with or without functional water intake in daily life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Intake of the test drink twice a day for 16 weeks
Interventions/Control_2
Intake of the placebo drink twice a day for 16 weeks
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who are aged from 35 to 65 years and do not meet the exclusion criteria.
2. Persons who can give written informed consents.
Key exclusion criteria
1. Persons who have previous history such as neurological disorder, nervous system disorder, cardiovascular disease, and other serious disease.
2. Persons who have previous history of nervous system disease such as unconsciousness, coma, convulsion, etc.
3. Persons who are in treatment.
4. Persons who have food allergy.
5. Persons who have vision disorder or auditory disorder.
6. Persons who are pregnant or breastfeed.
7. Persons who have previous history of vasovagal syncope during or after blood sampling.
8. Persons who are currently smoking.
9. Persons who are continuously intake electrolyzed hydrogen water or hydrogen water within two months before obtaining his/her informed consent in this trial.
10. Persons who are now participating in other clinical trials or participated in other clinical trials within two months before obtaining his/her informed consent in this trial.
11. Persons who cannot set a water purifier at home.
12. Persons who cannot follow the instructions for COVID-19 infection prevention.
13. Persons who are judged not suitable to participate in this trial by investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Watanabe |
Organization
RIKEN
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-304-7101
yywata@riken.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN
Division name
Laboratory for Pathophysiological and Health Science
Zip code
650-0047
Address
6-7-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-569-8868
Homepage URL
keimizuno@riken.jp
Sponsor or person
Institute
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
Ethics Committee of RIKEN
Address
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
Tel
078-306-3036
kobe-ankan@cdb.riken.jp
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
| 2024 | Year | 03 | Month | 31 | 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
51
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056676
