Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bobath Memorial Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | The control group does not participate in chewing gum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chewing gum | Other | chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of cortical thickness and brain network function | brain MRI (3D-T1 weighted images and resting state functional MRI) | Change from Baseline at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong Hye Choi, MD, PhD | Contact | 82 32 8902947 | seonghye@inha.ac.kr | |
| Hae Ri Na, MD, PhD | Contact | neuna102@paran.com |
| Name | Affiliation | Role |
|---|---|---|
| Hae Ri Na, MD, PhD | Bobath Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bobath Memorial Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13552 | South Korea |
The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Data will be available for 2 years since March 2025.
Reasonable request
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Inha University Hospital | Recruiting | Incheon | 22332 | South Korea |
|
| Ewha Womans Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Ajou University Hospital | Recruiting | Suwon | South Korea |
|
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |