Cognitive DeclineNCT01132261
Trial of a Brain Preservation Diet in Preventing Cognitive Decline in Old Age Hostel Residents
A study testing "brain preservation' diet in people with Cognitive Decline and Dietetic Intake, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Cognitive Decline, Dietetic Intake
- What is being tested?
- "brain preservation' diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Feb 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- old age home residents age 75 years or above, CDR<1
Who cannot join
- tube fed residents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cognitive Decline, Dietetic Intake
- Being tested
- "brain preservation' diet
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"brain preservation' dietOther
dietetic evaluation and advice in small group for health diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | brain preservation diet Receives: Other: "brain preservation' diet |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive decline
Measured: 33 months
Secondary outcomes (2)
Change in MMSE test
Measured: 33 months
% 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.
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132261
- Sponsor's protocol ID
- RCT-dietetic intake
- Other IDs
- CRE-2005.473
- Status last verified
- Jan 2009
- First submitted
- 25 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
Publications
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.
PubMed 22948946
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randonized Control Trial of a Brain Preservation Diet in Preventing Congnitive Decline in Odl Age Hostel Residents
- ClinicalTrials.gov ID
- NCT01132261
- Acronym / sponsor ID
- RCT-dietetic intake
- Conditions
- Cognitive Decline, Dietetic Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: "brain preservation' dietbrain preservation diet |
| 2 | No intervention | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- old age home residents age 75 years or above, CDR<1
Key exclusion criteria (1 listed)
- tube fed residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "brain preservation' dietdietetic evaluation and advice in small group for health diet | Other | 1 |
Primary outcome
cognitive decline
Time frame: 33 months
2 secondary outcomes
Change in MMSE test
Time frame: 33 months
% subjects meeting targets of brain preservation diet
Time frame: 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Derived from this study: PubMed 22948946Kwok 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "brain preservation' diet in people with Cognitive Decline and Dietetic Intake, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive decline (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.