UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046130 |
|---|---|
| Receipt number | R000052639 |
| Scientific Title | Effect of pre-meal chewing gum training on community-dwelling elderly people's awareness of ease of eating and masticatory / swallowing function |
| Date of disclosure of the study information | 2021/11/20 |
| Last modified on | 2021/11/20 17:54:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of pre-meal gum chewing programs on community-based elderly people's awareness of ease of eating, chewing ability, and swallowing ability
Acronym
The effect of the gum chewing program on chewing and swallowing power
Scientific Title
Effect of pre-meal chewing gum training on community-dwelling elderly people's awareness of ease of eating and masticatory / swallowing function
Scientific Title:Acronym
Effects of gum chewing programs on masticatory and swallowing functions
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use a questionnaire to clarify whether the habit of chewing gum before each meal leads to a subjective "ease of eating" in the elderly's diet. At the same time, changes in swallowing function, salivation volume and masticatory power are also evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
About awareness of ease of eating. Ask for answers using a 7-step Likert scale and free description using your own questionnaire.
Key secondary outcomes
1. 1. Swallowing function
1) Repeated saliva swallowing test (RSST)
2) 100mL drinking test (100WST)
3) EAT-10
2. 2. saliva
1) Oral wetness
2) Saliva production
3. 3. Chewing power
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform a 2-minute gum chewing program for 1 month before each meal.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy elderly people living in the area who are 65 years old or older at the time of obtaining consent
2. Oral intake Independent and no obvious dysphagia.
3. Gum can be used safely without any obvious deterioration in cognitive function.
Key exclusion criteria
1. Frequent saliva throat
2. Those who are undergoing dental treatment
3. Those who have pain when chewing
4. Those who have a habit of chewing gum before meals
5. Those who did not enter the group with good swallowing function in the 100 mL water drinking test with RSST 3 times or more.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kurachi |
Organization
International University of Health and Welfare Graduate School
Division name
Graduate School of Medical Welfare
Zip code
286-8686
Address
4-3, Koudzunomori,Narita-shi,Chiba JAPAN
TEL
0476-20-7701
mkurachi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Matsuzaki |
Organization
International University of Health and Welfare Graduate School
Division name
Graduate School of Medical Welfare
Zip code
107-8402
Address
4-1-26, Akasaka,Minato-ku,Tokyo JAPAN
TEL
03-5574-3900
Homepage URL
20s1203@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Graduate School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare University Ethics Review Board
Address
4-1-26, Akasaka,Minato-ku,Tokyo JAPAN
Tel
03-5574-3900
rinri-tky@iuhw.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
| 2021 | Year | 11 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 20 | Day |
Last modified on
| 2021 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052639
