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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01132261
First received: May 25, 2010
Last updated: May 27, 2010
Last verified: January 2009
  Purpose

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.


Condition Intervention
Cognitive Decline
Dietetic Intake
Other: "brain preservation' diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randonized Control Trial of a Brain Preservation Diet in Preventing Congnitive Decline in Odl Age Hostel Residents

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • cognitive decline [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in MMSE test [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • % subjects meeting targets of brain preservation diet [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 480
Study Start Date: February 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
brain preservation diet
Other: "brain preservation' diet
dietetic evaluation and advice in small group for health diet
No Intervention: 2

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • tube fed residents
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01132261

Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professsor, Thhe Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01132261     History of Changes
Other Study ID Numbers: RCT-dietetic intake, CRE-2005.473
Study First Received: May 25, 2010
Last Updated: May 27, 2010
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014