Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000098831
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
20/01/2012
Date last updated
23/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
DNA damage and Nutritional Profile of ApoE4 carriers, the Major Genetic Risk Factor for Alzheimer’s Disease
Scientific title
DNA Damage In Cells of Human ApoE4 Carriers and Prevention In vitro By Nutritional Supplementation with Lipophilic Antioxidants and Fatty Acids
Secondary ID [1] 279694 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 285524 0
Condition category
Condition code
Neurological 285712 285712 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to determine the DNA damage, lipid and micronutrient profile of ApoE4 carriers compared to non-carriers, and to determine if DNA damage in lymphocytes of ApoE4 carriers can be prevented with nutritional supplementation. A single fasted blood and cheek cell sample will be collected to determine DNA, micronutrient and fat content status, which may be associated with Alzheimer's disease. Dietary and lifestyle questionnaires and a short cognitive assessment will also be administered to measure mineral and vitamin intake and assess any lifestyle activities that may impact upon Alzheimer disease and dementia risk. All samples will be collected and questionnaires performed during the single visit. No dietary or drug treatment is involved. Recruitment will occur over approximately 5-6 months or until target sample size has been reached.
Intervention code [1] 283985 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286238 0
Determine DNA damage, micronutrient and lipid profile of ApoE4 carriers compared to non-carriers using the cytokinesis block micronucleus assay.
Timepoint [1] 286238 0
Only one sample collection is involved. Samples are set up fresh to determine DNA damage and lipid profile of the volunteers.
Secondary outcome [1] 295430 0
To determine if nutritional supplementation with lipophilic antioxidants and omega-3 fatty acids, in vitro can prevent DNA damage in ApoE4 carriers compared to non-carriers.
Timepoint [1] 295430 0
This is performed in the lab on lymphocytes isolated from the blood, once the DNA damage, micronutrient and lipid profiles have been established.

Eligibility
Key inclusion criteria
Inclusion Criteria
Aged 35-65 years; Healthy; Non-smokers; Male & Female
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:
Mini-mental State Examination (MMSE) score of less than 20. (short mental examination); Currently diagnosed with AD or Mild cognitive impairment; On Medication for life threatening diseases (i.e. chemotherapy); Taking mineral and vitamin supplements above the RDA level on a daily basis; Taking fish oil and antioxidant supplements investigated in the study; Unable to understand the study protocol

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284473 0
Government body
Name [1] 284473 0
Commonwealth Scientific and Industrial Research Organisation
Country [1] 284473 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation
Address
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, South Australia, Adelaide 5000
Country
Australia
Secondary sponsor category [1] 283399 0
None
Name [1] 283399 0
Address [1] 283399 0
Country [1] 283399 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Alzheimer’s disease (AD) is the most common form of dementia, currently affecting at least 35 million people worldwide and expected to double every 20 years. The risk of acquiring Alzheimer’s doubles every five years after the age of 65 and may be affected by common alterations in the fat transporter gene (APOE). The brain contains large proportions of fats such as cholesterol and omega-3 fatty acids. APOE plays a crucial role in maintaining healthy fat distribution such as cholesterol and omega-3 fatty acids, as well as brain cell repair and scavenging of toxins. Common alterations in the APOE gene, may directly or indirectly increase DNA damage and accelerate brain aging and degeneration. This disease is currently considered incurable and greatly highlights the need for preventative measures and therapeutic interventions, such as nutritional supplementation, that may improve DNA stability and mental health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33607 0
Address 33607 0
Country 33607 0
Phone 33607 0
Fax 33607 0
Email 33607 0
Contact person for public queries
Name 16854 0
Julia Weaver
Address 16854 0
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, South Australia, Adelaide 5000
Country 16854 0
Australia
Phone 16854 0
+61 08 83038976
Fax 16854 0
Email 16854 0
[email protected]
Contact person for scientific queries
Name 7782 0
Professor Michael Fenech
Address 7782 0
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, South Australia, Adelaide 5000
Country 7782 0
Australia
Phone 7782 0
+61 08 8303 8880
Fax 7782 0
Email 7782 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.