Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000467336
Ethics application status
Approved
Date submitted
27/08/2008
Date registered
17/09/2008
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effect of red wine and on Cytochrome p450 metabolites of arachidonic acid
Scientific title
The acute effect of red wine and dealcoholised red wine on Cytochrome p450 metabolites of arachidonic acid in healthy male adults
Secondary ID [1] 288316 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 3644 0
Condition category
Condition code
Cardiovascular 3810 3810 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men who drink>30g alcohol/day and <110g alcohol/day will participate in a randomised 3 period crossover design. The study will compare drinking 375ml of red wine, or the same volume of de-alcoholised red wine or water over a 30 min period with food. The 3 beverages will be administered in random order in a crossover design on 3 separate days. The 3 treatment days will be 2 weeks apart. During the 2 week intervals between treatment days volunteers will maintain their normal dietary and alcohol intake. Prior to each treatment day volunteers will abstain from drinking alcohol for 48 hrs, and will fast for 12hrs to before being studied. On each of the 3 treatment days, volunteers will have blood pressure (BP) monitored for 24hr. On each treatment day, cytochrome P450 metabolites of arachidonic acid will be measured in urine and in plasma and cell membranes before and after 2hrs, 4hr and 24hr of drinking the beverage .
Intervention code [1] 3327 0
Lifestyle
Comparator / control treatment
The dealcoholised red wine is the control for the red wine. the water is the control for the dealcoholised red wine
Control group
Active

Outcomes
Primary outcome [1] 4668 0
Changes in cytochrome P450 metabolites of arachidonic acid in urine, plasma cell membranes, between the treatments
Timepoint [1] 4668 0
baseline (0hrs) 2hrs, 4 hrs and 24hrs after the intervention is completed
Secondary outcome [1] 7890 0
Changes in ambulatory Blood pressure between the treatmants
Timepoint [1] 7890 0
blood pressure monitored over 24hours on each treatment day

Eligibility
Key inclusion criteria
alcohol consumption >30g/day <110gm/day, non-smokers, not taking medication
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
alcohol consumption <30g/day >110gm/day, smokers, 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)
Subjects enrolled after screening and medical examination by research nurse who requests treatment allocation from a statistician not involved in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
15/08/2007
Actual
7/09/2007
Date of last participant enrolment
Anticipated
Actual
6/06/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3792 0
Government body
Name [1] 3792 0
National Health and Medical Research of Australia (NH & MRC)
Country [1] 3792 0
Australia
Primary sponsor type
Individual
Name
Professor Kevin Croft
Address
School of Medicine & Pharmacology, Royal Perth Hospital
PO Box X2213 Perth. WA. 6847
Country
Australia
Secondary sponsor category [1] 3401 0
Individual
Name [1] 3401 0
Professor Lawrie Beilin
Address [1] 3401 0
Perth Hospital
PO Box X2213 Perth, WA. 6847
Country [1] 3401 0
Australia
Other collaborator category [1] 402 0
Individual
Name [1] 402 0
Dr Anne Barden
Address [1] 402 0
School of Medicine & Pharmacology, Royal Perth Hospital
PO Box X2213 Perth. WA. 6847
Country [1] 402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5851 0
University Of Western Austrlaia
Ethics committee address [1] 5851 0
35 Stirling Hwy, Nedlands, WA. 6009
Ethics committee country [1] 5851 0
Australia
Date submitted for ethics approval [1] 5851 0
Approval date [1] 5851 0
20/12/2006
Ethics approval number [1] 5851 0
RA/4/1/1661

Summary
Brief summary
Alcohol consumption is known to affect blood pressure regulation but the mechanism by which it does this is not known This project examines the role of certain fatty acid metabolites called cytochrome P450 metabolites of arachidonic acid (CYP450AA-M) acutely after drinking red wine de-alcohlised red wine or water. These fatty acid metabolites act on blood vessels causing them to constrict or dilate. In doing this they affect blood pressure regulation. The results of this study will determine how important CYP450AA-M are in regulating blood pressure acutely after consuming alcohol. We will study CYP450AA-M in cells as in plasma and urine in relation to blood pressure levels over 24hours.This project will help scientists decide how important these metabolites are for blood presssure regulation. If these metabolites are found to be important then it should be possible to alter their levels either by diet or drug treatment.
Trial website
Trial related presentations / publications
Publication Acute effects of red wine on cytochrome P450 eicosanoids and blood pressure in men. Anne E. Barden, Kevin D. Croft, Lawrence J. Beilin, Michael Phillips, Thomas Ledowski, and Ian B. Puddey Journal of Hypertension 2013, 31:2195–2202
Public notes

Contacts
Principal investigator
Name 28880 0
Prof Kevin
Address 28880 0
School of Medicine and Pharmacology GPO BOx X2213 Perth Western Australia, 6847
Country 28880 0
Australia
Phone 28880 0
61892240275
Fax 28880 0
Email 28880 0
kevin.croft@uwa.edu.au
Contact person for public queries
Name 12037 0
Professor Kevin Croft
Address 12037 0
School of Medicine and Pharmacology
GPO BOx X2213 Perth Western Australia, 6847
Country 12037 0
Australia
Phone 12037 0
0892240275
Fax 12037 0
0892240246
Email 12037 0
kevin.croft@uwa.edu.au
Contact person for scientific queries
Name 2965 0
Dr Anne Barden
Address 2965 0
School of Medicine and Pharmacology
GPO BOx X2213 Perth Western Australia, 6847
Country 2965 0
Australia
Phone 2965 0
0892240272
Fax 2965 0
0892240246
Email 2965 0
anne.barden@uwa.edu.au

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No Supporting Document Provided



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