UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027813 |
|---|---|
| Receipt number | R000031867 |
| Scientific Title | Prevention of frailty with a Japanese-style dietary habits -Kashiba Silver-agers Healthy Longevity project |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/12/20 09:37:07 |
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Basic information
Public title
Prevention of frailty with a Japanese-style dietary habits -Kashiba Silver-agers Healthy Longevity project
Acronym
Kashiba Silver-agers Healthy Longevity project (KASAHeL project)
Scientific Title
Prevention of frailty with a Japanese-style dietary habits -Kashiba Silver-agers Healthy Longevity project
Scientific Title:Acronym
Kashiba Silver-agers Healthy Longevity project (KASAHeL project)
Region
| Japan |
Condition
Condition
community-dwelling elderly
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between Japanese-style dietary habits and a prevention of frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevention of frailty
Key secondary outcomes
Nutritional status, grip strength, walking speed, cognitive function, and well-being
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Participants underwent baseline assessment in the Kashiba Silver-agers Healthy Longevity project
Key exclusion criteria
1) Already diagnosed as dementia
2) Highly vulnarable elders or severe disability at baseline
3) Serious chronic diseases as their diets may have altered
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Kanauchi |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
+81-745-54-1601
m.kanauchi@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Kanauchi |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
Homepage URL
m.kanauchi@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
JSPS, Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Other
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
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
| 2017 | Year | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is observational prospective study. Participant characteristics will be inveatigated for other relevant factors: sge, sex, body composition, major chronic diseases, physical activity, cognitive function, and well-being.
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031867
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
