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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032630
Receipt No. R000037205
Scientific Title Clinical study of the relationship between frailty and saliva components
Date of disclosure of the study information 2019/01/01
Last modified on 2019/08/13

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Basic information
Public title Clinical study of the relationship between frailty and saliva components
Acronym The relationship between frailty and saliva
Scientific Title Clinical study of the relationship between frailty and saliva components
Scientific Title:Acronym The relationship between frailty and saliva
Region
Japan

Condition
Condition frailty
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study determine whether frailty has an effect on the saliva components.
Basic objectives2 Others
Basic objectives -Others The analysis of saliva components in frailty
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The saliva components are analyses using metabolomic analysis and ELISA.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 When we show the change of saliva components and the index of frailty, we provide registered dietitian at the university hospital and primary care physician.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Residents in Samukawa Home or Honobono.
Patients in Kanagawa dental university hospital.
Key exclusion criteria Subject with percutaneous endoscopic gastrostomy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name To
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Department of Oral Science
Zip code 2380003
Address 82 Inaoka-cho, Yokosuka, Kanagawa
TEL 0468229537
Email m.tou@kdu.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name To
Organization Graduate School of Dentistry, Kanagawa Dental University
Division name Department of Oral Science
Zip code 2380003
Address 82 Inaoka-cho, Yokosuka, Kanagawa
TEL 0468229537
Homepage URL
Email m.tou@kdu.ac.jp

Sponsor
Institute Kanagawa Dental University
Institute
Department

Funding Source
Organization Kanagawa Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute for Advanced Biosciences, Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanagawa Dental University
Address 82 Inaoka-cho, Yokosuka, Kanagawa
Tel 0468229537
Email m.tou@kdu.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
2019 Year 01 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
2018 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037205

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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