Chewing Gum and Cognitive Function

Study Overview
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Brief Summary
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This study is to investigate whether the improvement or maintenance of cognitive function is superior to the control group when gum chewing is performed in elderly people with subjective cognitive decline or mild cognitive impairment.

Detailed Description
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The intervention group chew one unscented gum provided by the study for 12 weeks. Using KakaoTalk, the coordinator sends a chewing gum alarm. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting an authentication photo in the KakaoTalk chat room. The research coordinator checks the certification on a weekly basis and sends a separate phone call to encourage participants who do not chew gum more than twice a week.

Official Title
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Effect of Chewing Gum on Cognitive Function

Conditions
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Cognitive Dysfunction

Intervention / Treatment
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* Other: Chewing gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 to 79 years of age All posterior teeth are evenly occluded on both sides, and those who have lost 4 or less teeth in the posterior teeth Those who scored 50 points or less on the periodontal disease self-checklist Meet the diagnostic criteria for subjective cognitive decline or mild cognitive impairment Provide written informed consent Exclusion Criteria: Those who have difficulty in chewing due to toothache, periodontal disease, temporomandibular joint disease, severe malocclusion, shaking teeth, etc. Those who wear dentures on the upper or lower teeth Dementia Major psychiatric illness such as major depressive disorders Other neurodegenerative disease (e.g., Parkinson's disease) Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease, or any medical conditions preventing to complete the study as judged by the study physician Severe loss of vision, hearing, or communicative disability Significant laboratory abnormality that may result in cognitive impairment Any conditions preventing cooperation as judged by the study physician Coincident participation in any other intervention trial Those who are planning dental treatment such as preservation, prosthetics, and implants during the research period

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention group chew one unscented gum provided by the study for 12 weeks. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting a proof photo in the KakaoTalk chat room. | Other: Chewing gum<br>* chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.<br>|
| No Intervention: Control<br>The control group does not participate in chewing gum. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cognition | Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance. | Change from Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of global cognition | Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance. | Change from Baseline at 12 weeks | 
| Change of function | Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance. | Change from Baseline at 12 weeks | 
| Change of depression | Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood. | Change from Baseline at 12 weeks | 
| Change of activities of daily living | Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance. | Change from Baseline at 12 weeks | 
| Change of quality of life | Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance. | Change from Baseline at 12 weeks |