UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054134 |
|---|---|
| Receipt number | R000061636 |
| Scientific Title | Effect of water intake on biological indicators |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/11/01 15:56:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of water intake on biological indicators
Acronym
Effect of water intake on biological indicators
Scientific Title
Effect of water intake on biological indicators
Scientific Title:Acronym
Effect of water intake on biological indicators
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of water intake on biological indicators
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep efficiency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
NOT Water intake (6 days) -Washout period(1weeks)- Water intake (6 days)
Interventions/Control_2
Water intake (6 days) -Washout period(1weeks)- NOT Water intake (6 days)
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
| 50 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Men aged 50 to under 60 years at the time of consent.
2. Subjects who can make self-judgment and voluntarily gave informed consent.
Key exclusion criteria
1. Subjects with sleep-related disorders such as sleep apnea, lifestyle diseases, renal diseases, or urological diseases.
2. Those with pacemakers.
3. Subjects taking any supplements or undergoing treatment with medications (including OTC drugs).
4. Others who were judged as inappropriate for participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsutaka |
| Middle name | |
| Last name | OISHI |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Cellular and Molecular Biotechnology Research Institute
Zip code
305-8566
Address
Central 6 , 1-1-1 Higashi, Tsukuba, Ibaraki
TEL
050-3521-0274
k-ooishi@aist.go.jp
Public contact
Name of contact person
| 1st name | Katsutaka |
| Middle name | |
| Last name | OISHI |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Cellular and Molecular Biotechnology Research Institute
Zip code
305-8566
Address
Central 6, 1-1-1 Higashi, Tsukuba, Ibaraki
TEL
050-3521-0274
Homepage URL
k-ooishi@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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
AIST Tsukuba, Committee on Bioethics
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8561 Japan
Tel
029-861-2120
safe-life-ml@aist.go.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 | 05 | Month | 01 | 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
62
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
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061636
