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临床试验/NCT01132261
NCT01132261已完成不适用

A Randonized Control Trial of a Brain Preservation Diet in Preventing Congnitive Decline in Odl Age Hostel Residents

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
480
试验地点
1
主要终点
cognitive decline

研究概览

简要总结

Dementia is a major cause of disabilities in older people. If the onset of dementia can be delayed by preventive measures, the burden of the disease to the society can be greatly reduced. It is now recognised that dietary factors are related to the incidence of dementia. High intake of vegetables, fruit and fish are protective while high intake of saturated fat and salt (via its effect on blood pressure) are detrimental to risk of dementia.

The investigators therefore propose to perform a randomized controlled trial of dietetic interventions in old age hostels in Hong Kong. Twelve old age hostels under the Tung Wah Group will be randomly assigned to intervention or control groups. The intervention group will receive dietetic interventions by 2 weekly small group discussion with the residents, modification of menu and publicity. The daily diet to be implemented consists of the following principles: 1. fresh fruit 2 portions, 2. vegetables 4 portions, 3. fish, 4. white meat, 5. sodium intake < 100 mmol/L, 6. six glasses of water. In the control group. The dietician will give two health talks and advice on menu only.

The primary outcome is the incidence of questionable dementia in those who are normal at baseline and the incidence of dementia in those who have questionable dementia at baseline. The categorisation will be performed by trained research assistant after administering a structured questionnaire. Change in mini-mental examination score and SF36 quality of life scores are secondary outcomes. Food records over three days for each subject are recorded every three months, to ensure that the brain preservation diet has been adhered to. Half of the subjects will be randomly assigned to have blood and urine tests at baseline and at one year, in order to examine the health effects of dieting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • old age home residents age 75 years or above, CDR<1

排除标准

  • tube fed residents

结局指标

主要结局

cognitive decline

时间窗: 33 months

次要结局

  • Change in MMSE test(33 months)
  • % subjects meeting targets of brain preservation diet(33 months)

研究者

申办方类型
Other

研究点 (1)

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