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Trial registered on ANZCTR


Registration number
ACTRN12615000134527
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
12/02/2015
Date last updated
12/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of alcohol consumption on blood pressure in women
Scientific title
A randomised controlled trial of the effects of alcohol on ambulatory blood pressure in healthy pre-menopausal women
Secondary ID [1] 286086 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood pressure 294085 0
Condition category
Condition code
Cardiovascular 294393 294393 0 0
Hypertension
Diet and Nutrition 294394 294394 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During an initial 4-week run-in period, subjects continue their usual regular intake. They are then randomized into a 3 period cross-over study of Latin square design, during which they consume during sequential 4 week study periods:-

(1) 140-210 g/week (2-3 standard drinks/day) of alcohol as red wine (a shiraz cabernet blend of known composition and alcohol content - alcohol 13% v/v, sourced from Orlando Wyndham, Rowland Flat, South Australia) (approx. 2-3 bottles per week with a minimum consumption of 20 g per day every day and maximum consumption of 30 g per day every day),
or (2) 30-70 g/week of alcohol as the same red wine (approx. 0.5 to 1 bottle per week with a minimum consumption of 10 g per day on 3 of the 7 days and maximum consumption of 10 g per day every day),
or (3) as a control, an identical red wine but which was de-alcoholised (again sourced from Orlando Wyndham, Rowland Flat, South Australia) (approx. 2-3 bottles per week with equivalent volumes consumed daily matched to the high-alcohol period). During this 4-week period they otherwise remain abstinent from all alcohol.

There was no washout period between each 4-week study period.

The precise amount of red wine and de-alcoholised red wine within the above ranges is dictated by each subject's usual alcohol intake at entry to the study. Entry to each intervention phase of the study is scheduled so that measurement of blood pressure and lipid levels correspond as closely as possible to the early follicular phase of each subject's menstrual cycle. This is to minimize any confounding from differences in hormone levels within and between subjects resulting from phase of the menstrual cycle.

All measurements are performed at the end of the 4-week run-in period and each of the three 4-week study periods.

Compliance with the designated changes in alcohol intake are recorded by 7-day retrospective weekly diaries, completed at weekly visits to the clinical trials unit. In addition serum is sampled at the end of the 4-week
run-in period and the end of each subsequent study period for both gamma-glutamyl transpeptidase and carbohydrate deficient transferrin as biomarkers of alcohol intake. Twenty-four hour urinary 4-Omethylgallic acid is determined as a biomarker of red wine intake.
Intervention code [1] 291079 0
Lifestyle
Comparator / control treatment
As a control, an identical red wine but which was de-alcoholised (again sourced fromOrlando Wyndham, Rowland Flat, South Australia ) (approx. 2-3 bottles per week with equivalent volumes consumed daily matched to the high-alcohol period). During this 4-week period they otherwise remain abstinent from all alcohol. The precise amount of de-alcoholised red wine is dictated by each subject's usual alcohol intake at entry to the study.
Control group
Active

Outcomes
Primary outcome [1] 294192 0
24hr, daytime and night time ambulatory blood pressure level

24-hour ambulatory BP measurement is performed using a SpaceLabs Monitor (Model 90217, SpaceLabs Medical Inc) while subjects continue their normal routine. The recorder is preset to take BP and heart rate (HR) recordings every 30 min and is fitted at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period. BP records are not visible to the subjects. Subjects are instructed to complete an activity diary which describes the posture and activity of the subject at the time of the BP reading. While the BP measurements are being made, subjects are instructed to keep their arm motionless by their side to avoid artefactual readings caused by vibration. In cases when the SpaceLabs Monitor detects an error in BP measurement subjects are instructed to rectify the error or return to the department to have the recorder corrected. Readings associated with a test code and those with a difference of < 20 mmHg between SBP and DBP are excluded from analysis. Mean BP and HR are calculated for each of the 24 hours and then mean 24 hour, awake and asleep BP and HR are computed. Waking and sleeping times are determined from subjects’ activity diaries.

Timepoint [1] 294192 0
At the end of the 4 week run-in period and at the end of each of the 3 4-week study periods.
Secondary outcome [1] 312728 0
24hr, daytime and night time ambulatory heart rate

24-hour ambulatory HR measurement is performed using a SpaceLabs Monitor (Model 90217, SpaceLabs Medical Inc) while subjects continue their normal routine. The recorder is preset to take HR recordings every 30 min and is fitted at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period. Subjects are instructed to complete an activity diary which describes the posture and activity of the subject at the time of the HR reading. Mean HR is calculated for each of the 24 hours and then mean 24 hour, awake and asleep HR is computed. Waking and sleeping times are determined from subjects’ activity diaries.
Timepoint [1] 312728 0
At the end of the 4 week run-in period and at the end of each of the 3 4-week study periods.
Secondary outcome [2] 312729 0
HDL-cholesterol

Blood was collected after an overnight fast. Serum samples were analysed on the day of venipuncture by Core Laboratory Services, Royal Perth Hospital, using the Hitashi 917 Biochemical Analyser (Hitachi Limited, Tokyo, Japan) and with HDL cholesterol measured with the Boehringer Mannheim kit (Cat No. 1930648) (Interassay CV 3.0%; normal reference range 0.9 – 2.0 mmol/L).
Timepoint [2] 312729 0
At the end of the 4 week run-in period and at the end of each of the 3 4-week study periods.

Eligibility
Key inclusion criteria
Women 20-45 years of age, pre-menopausal and regularly drinking in the range of 140 to 210 g/wk ethanol (equivalent to approximately 14 and 21 standard drinks). BMI will be < 30 kg/m2 and subjects will be non-smokers. They will be otherwise healthy, free of clinical evidence of vascular disease on examination.
Minimum age
20 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Past history of hypertension, dyslipidaemia, diabetes mellitus or liver disease.
Past history of coronary disease, cerebrovascular disease or peripheral vascular disease.
Any regular medication, including aspirin, non-steroidal anti-inflammatory drugs or the oral contraceptive pill.

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)
Concealment by central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The 24 hr ambulatory BP records were analysed utilising pooled time series regression with random effects models adjusted for serial correlation. It was estimated that with change in 24 hr ambulatory systolic BP as the major endpoint there would be at least 80% power to demonstrate a 2-3 mmHg change in systolic BP. We estimated that with 3 separate study periods and an adjusted alpha level of 0.05/3 (assuming the potential for 3 paired comparisons), that a minimum of 32 subjects would be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3392 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 9167 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 290672 0
Charities/Societies/Foundations
Name [1] 290672 0
National Heart Foundation of Australia
Address [1] 290672 0
National Heart Foundation of Australia
Victorian Division
411 King Street
WEST MELBOURNE VIC 3003
Country [1] 290672 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 289365 0
Individual
Name [1] 289365 0
Prof Ian B Puddey
Address [1] 289365 0
School of Medicine and Pharmacology
Faculty of Medicine, Dentistry and Health Sciences
University of Western Australia
RPH MRF Building
Rear 50 Murray St, Perth, WA 6000
Country [1] 289365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292302 0
Human Research Ethics Committee, University of Western Australia
Ethics committee address [1] 292302 0
Human Research Ethics Committee
Research Ethics, Research Services
M459 University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Ethics committee country [1] 292302 0
Australia
Date submitted for ethics approval [1] 292302 0
Approval date [1] 292302 0
11/06/2003
Ethics approval number [1] 292302 0
Project No 0752

Summary
Brief summary
Alcohol consumption by Australian women, especially younger women, has been steadily increasing together with the prevalence of episodic or binge drinking by such subjects. The increase in alcohol intake has been occurring in the setting of an increased public health recognition that the regular consumption of 1-2 standard alcoholic drinks per day may confer protection against coronary artery disease. However, the balance of potential risks and benefits for alcohol consumption have, more often than not, been generated on the basis of data from studies in men. This is especially true with respect to the effects of alcohol on blood pressure and hypertension. There is continuing controversy with respect to the amount of alcohol which will influence blood pressure in women and uncertainty as to the direction of any effect. Population-based epidemiological studies suggest that low level alcohol consumption (4-7 drinks per week) may lower blood pressure in women while higher levels of consumption (2 or more drinks per day) have been associated with higher levels of blood pressure. The present proposal will directly test these assumptions by measuring BP over 24 hr on a carefully controlled basis in women who are drinking at these levels over 4-week periods. The results will be compared to levels of BP measured after 4 weeks of abstinence from all alcohol.
Trial website
Trial related presentations / publications
Puddey IB, Mori TA, Burke V, Dunbar D, Beilin LJ. The effects of red wine on ambulatory blood pressure in pre-menopausal women: a controlled intervention study. 2005; 23 (Supplement 2):S63.
Public notes

Contacts
Principal investigator
Name 54558 0
Prof Ian B Puddey
Address 54558 0
School of Medicine and Pharmacology
Faculty of Medicine, Dentistry and Health Sciences
University of Western Australia
RPH MRF Building
Rear 50 Murray St, Perth, WA 6000
Country 54558 0
Australia
Phone 54558 0
+61 8 92240232 or +61 8 92240258
Fax 54558 0
Email 54558 0
Ian.Puddey@uwa.edu.au
Contact person for public queries
Name 54559 0
Prof Ian B Puddey
Address 54559 0
School of Medicine and Pharmacology
Faculty of Medicine, Dentistry and Health Sciences
University of Western Australia
RPH MRF Building
Rear 50 Murray St, Perth, WA 6000
Country 54559 0
Australia
Phone 54559 0
+61 8 92240232 or +61 8 92240258
Fax 54559 0
Email 54559 0
Ian.Puddey@uwa.edu.au
Contact person for scientific queries
Name 54560 0
Prof Ian B Puddey
Address 54560 0
School of Medicine and Pharmacology
Faculty of Medicine, Dentistry and Health Sciences
University of Western Australia
RPH MRF Building
Rear 50 Murray St, Perth, WA 6000
Country 54560 0
Australia
Phone 54560 0
+61 8 92240232 or +61 8 92240258
Fax 54560 0
Email 54560 0
Ian.Puddey@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary