An interventional study of Chewing gum in Cognitive Dysfunction, sponsored by Inha University Hospital. Recruiting at 4 sites in Korea, Republic of. Open to participants aged 60 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Inha University Hospital · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
The control group does not participate in chewing gum.
chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
Time frame: Change from Baseline at 12 weeks
Change of global cognition
Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance.
Time frame: Change from Baseline at 12 weeks
Change of function
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Time frame: Change from Baseline at 12 weeks
Change of depression
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline at 12 weeks
Change of cortical thickness and brain network function
brain MRI (3D-T1 weighted images and resting state functional MRI)
Time frame: Change from Baseline at 12 weeks
Plan to share: Yes — The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Supporting information: Study protocol, Sap, Csr, Analytic code
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Inha University Hospital