Trial of a Brain Preservation Diet in Preventing Cognitive Decline in Old Age Hostel Residents
Primary Purpose
Cognitive Decline, Dietetic Intake
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
"brain preservation' diet
Sponsored by

About this trial
This is an interventional prevention trial for Cognitive Decline
Eligibility Criteria
Inclusion Criteria:
- old age home residents age 75 years or above, CDR<1
Exclusion Criteria:
- tube fed residents
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
brain preservation diet
Outcomes
Primary Outcome Measures
cognitive decline
Secondary Outcome Measures
Change in MMSE test
% subjects meeting targets of brain preservation diet
brain preservation diet includes 3 portion of vergetables per day, 2 portion of fruit per day, 5 meal of fish per week, 6 glasses of water per day.
Full Information
NCT ID
NCT01132261
First Posted
May 25, 2010
Last Updated
May 27, 2010
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01132261
Brief Title
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
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Dietetic Intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
brain preservation diet
Arm Title
2
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
"brain preservation' diet
Intervention Description
dietetic evaluation and advice in small group for health diet
Primary Outcome Measure Information:
Title
cognitive decline
Time Frame
33 months
Secondary Outcome Measure Information:
Title
Change in MMSE test
Time Frame
33 months
Title
% subjects meeting targets of brain preservation diet
Description
brain preservation diet includes 3 portion of vergetables per day, 2 portion of fruit per day, 5 meal of fish per week, 6 glasses of water per day.
Time Frame
33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
old age home residents age 75 years or above, CDR<1
Exclusion Criteria:
tube fed residents
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22948946
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.
Results Reference
derived
Learn more about this trial
Trial of a Brain Preservation Diet in Preventing Cognitive Decline in Old Age Hostel Residents
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