Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000207314
Ethics application status
Approved
Date submitted
15/04/2008
Date registered
17/04/2008
Date last updated
5/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of red wine consumption on Cytochrome P450 metabolites of arachidonic acid
Scientific title
The effect of alcohol and polyphenol consumption on Cytochrome P450 metabolites of arachidonic acid
Secondary ID [1] 283420 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and polyphenol consumption on Cytochrome P450 metabolites 3055 0
Condition category
Condition code
Diet and Nutrition 3211 3211 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men who drink 40g of alcohol/day will be invited to participate in a 12 week trial of randomized block design, during which they will substitute the alcohol they drink for either 375 mol of water, or the equvalent volume of de-alcoholised red wine or red wine each for 4 weeks in crossover design without washout periods.
Intervention code [1] 2803 0
Lifestyle
Comparator / control treatment
The de-alcoholised red wine is the control for the red wine. The water is the control for the de-alcoholised red wine.
Control group
Dose comparison

Outcomes
Primary outcome [1] 4095 0
Changes in Cytochrome P450 metabolites of Arachidonic acid in urine, plasma, cell membranes. between the treatments will be assessed using gas chromatography mass spectrometry
Timepoint [1] 4095 0
4, 8, and 12 weeks
Primary outcome [2] 4096 0
Changes in ambulatory Blood pressure. between the treatments
Timepoint [2] 4096 0
4,8,and 12 weeks
Secondary outcome [1] 6896 0
Plasma and urinary F2-isoprostanes measured using gas chromatography mass spectrometry
Timepoint [1] 6896 0
4,8 and 12 weeks
Secondary outcome [2] 320541 0
Plasma Resolvins
Timepoint [2] 320541 0
4,8, and 12 weeks

Eligibility
Key inclusion criteria
alcohol consumption >30g/day<110g/day, non-smokers, not taking medication
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking, alcohol consumption <30g/day or >110g/day. Taking medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by a statistician not involved in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
three period open label crossover study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2008
Actual
21/04/2008
Date of last participant enrolment
Anticipated
Actual
9/02/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 3305 0
Government body
Name [1] 3305 0
NH&MRC
Country [1] 3305 0
Australia
Primary sponsor type
University
Name
University of Western Austrlaia
Address
Stirling Hwy,
Nedlands
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 2957 0
Hospital
Name [1] 2957 0
Royal Perth Hospital
Address [1] 2957 0
Wellington Street
Perth,6001
Country [1] 2957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5290 0
Univeristy of Western Australia
Ethics committee address [1] 5290 0
Ethics committee country [1] 5290 0
Australia
Date submitted for ethics approval [1] 5290 0
Approval date [1] 5290 0
20/12/2006
Ethics approval number [1] 5290 0
RA/4/1/1661
Ethics committee name [2] 5291 0
Royal Perth Hospital
Ethics committee address [2] 5291 0
Ethics committee country [2] 5291 0
Australia
Date submitted for ethics approval [2] 5291 0
Approval date [2] 5291 0
26/02/2007
Ethics approval number [2] 5291 0
RA-07/003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28532 0
Prof Kevin Croft
Address 28532 0
School of Medicine & Pharmacology, GPO BOX X2213 Perth, Western Australia
Country 28532 0
Australia
Phone 28532 0
618 9224 0275
Fax 28532 0
Email 28532 0
[email protected]
Contact person for public queries
Name 11689 0
Professor Kevin Croft
Address 11689 0
School of Medicine & Pharmacology,
GPO BOX X2213 Perth, Western Australia
Country 11689 0
Australia
Phone 11689 0
08 92240275
Fax 11689 0
0892240246
Email 11689 0
[email protected]
Contact person for scientific queries
Name 2617 0
Dr Anne Barden
Address 2617 0
School of Medicine & Pharmacology,
GPO BOX X2213 Perth, Western Australia
Country 2617 0
Australia
Phone 2617 0
089224 0272
Fax 2617 0
089224 0246
Email 2617 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.