Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000013268
Ethics application status
Approved
Date submitted
6/11/2008
Date registered
8/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of de-alcoholised wine on Deoxyribonucleic Acid (DNA) damage.
Scientific title
Effects of de-alcoholised red and white wine on spontaneous and oxidative damage to Deoxyribonucleic Acid (DNA) in healthy women.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of spontaneous and oxidative damage to DNA in healthy women 4016 0
Condition category
Condition code
Diet and Nutrition 4221 4221 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to 1 of 3 treatments. 1 acute day (once per week for 3 weeks) of 600ml of red or white de-alcoholised wine given as a drink (to be entirely consumed within 10 minutes of the baseline blood sample being collected) compared with 600ml water as the control (to be completely consumed within 10 minutes of the baseline blood sample being collected).
Each participant will be involved for 3 weeks. On day one of the first week, each participant will be randomised to one of the study drinks or the control drink. At visit 2 (one week later) the participant will be randomised to either one of the remaining study drinks or control drink. At the third visit (one week after visit 2), participants will consume either the remaining study drink or control drink. Participants will refrain from foods and beverages containing polyphenolic compounds for 24 hours prior to each of their 3 weekly visits, and will fast (water allowed) for 10 hours prior to each visit. Week 1: Following the last blood sample being collected on the morning of each visit, the participants will resume their usual diet until 24 hours prior to each of their second and 3rd clinic visits.
There will be two groups of 4 participants on this trial over a six week period. Each group of 4 participants will complete 3 consecutive weeks on the study. The 7 days between each visit is the washout period.
Intervention code [1] 3740 0
Prevention
Comparator / control treatment
600ml water to be consumed within 10 minutes of the baseline blood sample collection
Control group
Active

Outcomes
Primary outcome [1] 5225 0
Primary outcome measures will be oxidative dna damage which will be measured by determining micronucleus frequency using the cytokinesis-block micronucleus assay scored by visual microscopy.
Timepoint [1] 5225 0
Timepoint -10mins - fasting baseline blood sample; Time point 0 - consume 600ml study drink or control within 10 minutes;
Timepoint 1.0hr post drink blood sample;
Timepoint 2.0hr post drink blood sample.
Secondary outcome [1] 8808 0
the secondary outcome measures will be nucleoplasmic bridges, nuclear buds, cell death and nuclear division index, which will be measured using the cytokinesis-block micronucleus assay scored by visual microscopy.
Timepoint [1] 8808 0
Timepoint -10mins - fasting baseline blood sample; Time point 0 - consume 600ml study drink or control within 10 minutes;
Timepoint 1.0hr post drink blood sample;
Timepoint 2.0hr post drink blood sample.

Eligibility
Key inclusion criteria
Healthy females; aged 25 - 50 years; willing to refrain from consuming polyphenolic-rich food/beverages for 24 hours prior to each study day(e.g. red and/or white wine); females who drink red and white wine.
Minimum age
25 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cigarette smoker currently or within the past six months; receiving medical treatment including anti-folate drugs currently or within the past six months e.g. aminopterin (AMT) and methotrexate (MTX); planning a pregnancy or currently pregnant; females allergic to compounds present in red and white wines.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are screened for inclusion and exclusion criteria and once deemed eligible are randomly allocated into one of the 3 treatments. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using the computer software "Clinstat".
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4125 0
Commercial sector/Industry
Name [1] 4125 0
Australian Vintage Ltd
Country [1] 4125 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australian Vintage Ltd
Address
Level 2, 170 Greenhill Road
Parkside SA 5063
Country
Australia
Secondary sponsor category [1] 3711 0
Government body
Name [1] 3711 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
Address [1] 3711 0
Gate 13 Kintore Avenue
ADELAIDE SA 5000
Country [1] 3711 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6196 0
CSIRO Human Nutrition Human Research Ethics Committee
Ethics committee address [1] 6196 0
Gate 13 Kintore Avenue Adelaide SA 5000
Ethics committee country [1] 6196 0
Australia
Date submitted for ethics approval [1] 6196 0
Approval date [1] 6196 0
14/08/2008
Ethics approval number [1] 6196 0
08/16

Summary
Brief summary
Aim: A study investigating the bio-efficiency of de-alcoholised red and white wine as an antioxidant in humans using both red and white wine formulas. The study will be split into two 3 week blocks. Each participant will be involved for only 3 consecutive weeks.
Recruitment: 8 healthy females are required.
Study design: Participants will fast for 10 hours overnight (water allowed) prior to each study day. During the 24 hours prior to each visit, participants will be asked to refrain from consuming foods/drinks that are rich in polyphenolic compounds (a list will be provided to them). In the first week, participants will be randomised to one of 3 treatments. In the second week, participants will be randomised to one of the remaining 2 treatments and in the third week, participants will cross over to the last treatment. Drinks will be blinded to minimise any impact on the outcomes of the research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29002 0
Address 29002 0
Country 29002 0
Phone 29002 0
Fax 29002 0
Email 29002 0
Contact person for public queries
Name 12159 0
Vanessa Courage
Address 12159 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue
ADELAIDE SA 5000
Country 12159 0
Australia
Phone 12159 0
+61 8 83038988
Fax 12159 0
+61 8 83038899
Email 12159 0
[email protected]
Contact person for scientific queries
Name 3087 0
Michael Fenech
Address 3087 0
CSIRO Human Nutrition
Gate 13 Kintore Avenue
ADELAIDE SA 5000
Country 3087 0
Australia
Phone 3087 0
+61 8 83038880
Fax 3087 0
+61 8 83038899
Email 3087 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.