Trial of a Brain Preservation Diet in Preventing Cognitive Decline in Old Age Hostel Residents

Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132261
• Other study ID #: RCT-dietetic intake
• Secondary ID: CRE-2005.473
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: May 27, 2010
• Start date: February 2006
• Est. completion date: June 2009

Study information

• Verified date: January 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• tube fed residents

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Dietetic Intake

Intervention

Other:
• "brain preservation' diet
dietetic evaluation and advice in small group for health diet

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive decline		33 months	No
Secondary	Change in MMSE test		33 months	No
Secondary	% 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.	33 months	No