UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041945 |
|---|---|
| Receipt number | R000047862 |
| Scientific Title | The effects of natural reduced water on body composition and cognitive function in older adults |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2022/09/27 15:38:50 |
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Basic information
Public title
The effects of natural reduced water on body composition and cognitive function in older adults
Acronym
The effects of natural reduced water on body composition and cognitive function in older adults
Scientific Title
The effects of natural reduced water on body composition and cognitive function in older adults
Scientific Title:Acronym
The effects of natural reduced water on body composition and cognitive function in older adults
Region
| Japan |
Condition
Condition
body composition/cognitive function/psychological function
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of natural reduced water on body composition and cognitive function in old adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*cognitive function(Executive function, short-term memory, attention function)
*body composition(body water content, body fat percentage, muscle mass)
*psychological function(subjective well-being, stress level, anxiety level)
*timing of evaluation:6 months or 12 months after the start of the intervention
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
Drink 1L of natural reduced water daily for 6 months
Interventions/Control_2
Drink 1L of tap water daily for 6 months
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Old adults over 60 years old(regardless of gender)
Key exclusion criteria
*Persons who cannot give informed consent
*Persons with a history of diabetes and hyperlipidemia
*Persons with severe visual or hearing disabilities
*Persons who have continuously drank natural reduced water in the last year
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Institute of Development, Aging and Cancer, Tohoku University.
Division name
Smart-Aging Research Center, Tohoku University.
Zip code
980-8575
Address
4-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takamitsu |
| Middle name | |
| Last name | Shinada |
Organization
Institute of Development, Aging and Cancer, Tohoku University.
Division name
Smart-Aging Research Center, Tohoku University.
Zip code
980-8575
Address
4-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-8824
Homepage URL
takamitsu.shinada.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Hita Tenryo-Sui 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 Tohoku University Graduate School of Medicine
Address
2-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
| 2020 | Year | 09 | Month | 30 | 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
100
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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047862
