UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040819 |
|---|---|
| Receipt number | R000046502 |
| Scientific Title | Research on prevention of low nutritional state for elderly person using chewing-gum |
| Date of disclosure of the study information | 2020/06/18 |
| Last modified on | 2020/06/18 11:37:46 |
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Basic information
Public title
Research on prevention of low nutritional state for elderly person using chewing-gum
Acronym
Research on prevention of low nutritional state for elderly person using chewing-gum
Scientific Title
Research on prevention of low nutritional state for elderly person using chewing-gum
Scientific Title:Acronym
Research on prevention of low nutritional state for elderly person using chewing-gum
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Objective of this research is the improvement of oral function of elderly person using chewing-gum to prevent the low nutritional state and to improve the dietary life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of masticatory ability by chewing gum test
Measurement of tongue pressure by pressure measuring apparatus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group given chewing-gum
Chewing-gum is given for 2 months, 3 times a day (breakfast, lunch, dinner), one piece a time.
Interventions/Control_2
Group not given chewing-gum
Control group not chewing gum for 2 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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An elderly person over 65 years old living at home.
He (She) can have a meal by oneself and can chew gums.
Key exclusion criteria
A person who have a medical history of systemic disease and severe mental illness
A person who can not understand explanation to acquire informed consent
A case that a principal investigator assesses unsuitability for examination
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazumune |
| Middle name | |
| Last name | Arikawa |
Organization
Nihon University School of Dentistry at Matsudo.
Division name
Department of Community Oral Health
Zip code
271-8587
Address
870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL
047-360-9353
arikawa.kazumune@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumune |
| Middle name | |
| Last name | Arikawa |
Organization
Nihon University School of Dentistry at Matsudo.
Division name
Department of Community Oral Health
Zip code
271-8587
Address
870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL
047-360-9353
Homepage URL
arikawa.kazumune@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo.
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo.
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
Nihon University School of Dentistry at Matsudo.
Address
870-1 Sakaecho, Nishi-2, Matsudo, Chiba
Tel
047-360-9353
arikawa.kazumune@nihon-u.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 | 06 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046502
| 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 |
