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临床试验/NCT05865340
NCT05865340已完成不适用

To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
diet

研究概览

简要总结

At present, many literatures have confirmed that the Mediterranean diet has the effect of delaying cognitive degeneration in patients with mild cognitive impairment, and can also slow down the speed of brain atrophy. In addition to the highly respected Mediterranean diet every year, several years of foreign research have found The maintenance of oral hygiene also has a significant relationship with the decline of cognitive function. The intervention of "oral hygiene" is a new intervention method that has started in recent years. Oral health will affect the overall health status, physical function, diet and nutritional status of the elderly. In particular, older adults with poor oral health are more likely to suffer from mild cognitive impairment. The relationship between oral health and nutrition and overall health is inseparable. If the concept of healthy eating (Mediterranean diet) recognized by the public is used and oral health education is involved at the same time. To allow patients with mild cognitive impairment to maintain oral health care in daily life, and to increase the knowledge of the Mediterranean diet and try to follow the rules of the Mediterranean diet, whether there is a more significant impact on these patients.

详细描述

This trial is expected to enroll 120 subjects, which will be accepted by the relevant researchers who carry out this study. In the pre-test part, all subjects will receive the Montreal Intelligence Test (MoCA) and Mini Intelligence Examination (MMSE) and collect MEDAS-14 Item, Oral Health Assessment Tool, OHAT and evaluation data of Taiwan Frailty Criteria of Taiwan. After completing the 12-week oral health and Mediterranean diet education intervention, all subjects will undergo post-test follow-up evaluation (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria), and all subjects will be assessed 12 weeks after the intervention The subjects were followed up with follow-up cognitive function tracking (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria). Finally, all the data were statistically analyzed to study which of the individual measures and the combined measures had a more significant cognitive effect on MCI patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over or equal to 50 years old
  • CDR score is less than or equal to 0.5 or MMSE score is 24-30 (including 24 and 30)
  • Conscious/complaint of cognitive decline

排除标准

  • Acute and significant mental illness in the past three months
  • Acute serious medical and surgical diseases in the past three months
  • Symptoms of delusions, hallucinations or delirium in the past three months
  • Severe visual and hearing impairment in the past three months
  • Other conditions that make the patient unable to cooperate: such as not being suitable after screening, not signing the subject's consent form.

结局指标

主要结局

diet

时间窗: 6 months

MEDAS-14 item

oral health

时间窗: 6 months

OHAT

cognitive

时间窗: 6 months

MoCA\&MMSE

frailty

时间窗: 6 months

Frailty Criteria

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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