Clinical trial NCT01132261: Trial of a Brain Preservation Diet in Preventing Cognitive Decline in Old Age Hostel Residents
Official title: A Randonized Control Trial of a Brain Preservation Diet in Preventing Congnitive Decline in Odl Age Hostel Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Dietetic Intake
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 480
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* tube fed residents

Primary outcomes:
measure: cognitive decline
timeFrame: 33 months
Secondary outcomes:
measure: Change in MMSE test
timeFrame: 33 months
measure: % subjects meeting targets of brain preservation diet
timeFrame: 33 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
Study officials:
References:
citation: Kwok TC, Lam LC, Sea MM, Goggins W, Woo J. A randomized controlled trial of dietetic interventions to prevent cognitive decline in old age hostel residents. Eur J Clin Nutr. 2012 Oct;66(10):1135-40. doi: 10.1038/ejcn.2012.117. Epub 2012 Sep 5.