Effect of Chewing Gum on Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Change of cognition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Intervention
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.
干预措施: Chewing gum (Other)
Control
The control group does not participate in chewing gum.
结局指标
主要结局
Change of cognition
时间窗: Change from Baseline at 12 weeks
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
次要结局
- Change of function(Change from Baseline at 12 weeks)
- Change of activities of daily living(Change from Baseline at 12 weeks)
- Change of global cognition(Change from Baseline at 12 weeks)
- Change of depression(Change from Baseline at 12 weeks)
- Change of quality of life(Change from Baseline at 12 weeks)