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

May 27, 2010 updated by: Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • tube fed residents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 2
ACTIVE_COMPARATOR: 1
brain preservation diet
Other: "brain preservation' diet
dietetic evaluation and advice in small group for health diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive decline
Time Frame: 33 months
33 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MMSE test
Time Frame: 33 months
33 months
% subjects meeting targets of brain preservation diet
Time Frame: 33 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (ESTIMATE)

May 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-dietetic intake
  • CRE-2005.473

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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