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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027813
Receipt No. 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

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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
Email 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
Email m.kanauchi@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031867

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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