UMIN-CTR Clinical Trial

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
Email	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
Email	20s1203@g.iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare Graduate School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052639