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

NCT ID: NCT01132261

Last Updated: 2010-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-06-30

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.

Conditions

Cognitive Decline; Dietetic Intake

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

brain preservation diet

Group Type: ACTIVE_COMPARATOR

"brain preservation' diet

Intervention Type: OTHER

dietetic evaluation and advice in small group for health diet

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"brain preservation' diet

dietetic evaluation and advice in small group for health diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• tube fed residents

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Thhe Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 22948946 (View on PubMed)

Other Identifiers

CRE-2005.473

Identifier Type: -

Identifier Source: secondary_id

RCT-dietetic intake

Identifier Type: -

Identifier Source: org_study_id