Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000445875
Ethics application status
Approved
Date submitted
10/04/2012
Date registered
19/04/2012
Date last updated
1/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beetroot juice lowers blood pressure
Scientific title
The effect of beetroot juice on lowering blood pressure in free-living individuals
Secondary ID [1] 280289 0
Nil
Universal Trial Number (UTN)
U1111-1129-8711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 286246 0
Condition category
Condition code
Cardiovascular 286462 286462 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was designed as a randomised, placebo controlled cross-over study with a 2 week washout period. Volunteers consumed a single dose of 500g of Sunraysia Beetroot and Apple Juice in the institute clinic over 5 - 10 minutes. Systolic / diastolic blood pressure and pulse rate was then monitored over the following 24 hours using an ambulatory blood pressure monitor. Volunteers were asked to avoid moderate or vigorous physical activity on the day of the trial, but no other restrictions, such as diet, were required of volunteers, either on intervention days or during the washout period.
Intervention code [1] 284643 0
Lifestyle
Intervention code [2] 284712 0
Prevention
Comparator / control treatment
500g of placebo juice consisting of apple juice concentrate base matched to the beetroot & apple juice for sweetness (sucrose) and colour (carmine red and rubini red)
Control group
Placebo

Outcomes
Primary outcome [1] 286912 0
Change in systolic blood pressure relative to control using an ambulatory blood pressure monitor.
Timepoint [1] 286912 0
At any given time point within 24 hours after consuming the beetroot and apple juice
Primary outcome [2] 286913 0
Change in diastolic blood pressure relative to control using an ambulatory blood pressure monitor.
Timepoint [2] 286913 0
At any given time point within 24 hours after consuming the beetroot and apple juice
Secondary outcome [1] 296977 0
Change in pulse pressure relative to control using an ambulatory blood pressure monitor.
Timepoint [1] 296977 0
At any given time point within 24 hours after consuming the beetroot and apple juice

Eligibility
Key inclusion criteria
Resting baseline systolic blood pressure greater than 120 mmHg on first day of treatment. No upper limit on systolic blood pressure - hypertensive subjects also eligible
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant
Lactating
Diabetes
On blood pressure medication

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)
Both the researcher who determiend if the subject was eligible for inclusion in the trial, and the subject, we not aware if the subject would be allocated to the treatment or the placebo first. Allocation was centrally performed by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285060 0
Commercial sector/Industry
Name [1] 285060 0
The Sunraysia Natural Beverage Company
Country [1] 285060 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart & Diabetes Institute
Address
75 Commercial Rd
Prahran
VIC 3181
Country
Australia
Secondary sponsor category [1] 283923 0
None
Name [1] 283923 0
Address [1] 283923 0
Country [1] 283923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287065 0
The Alfred human Research Ethics Committee
Ethics committee address [1] 287065 0
Ground Floor, Linay Pavilion,
The Alfred Hospital,
Commercial Road,
Melbourne.
VIC 3004.
Ethics committee country [1] 287065 0
Australia
Date submitted for ethics approval [1] 287065 0
20/09/2011
Approval date [1] 287065 0
26/09/2011
Ethics approval number [1] 287065 0
Approval number 377/11

Summary
Brief summary
The trial aims to assess the potential benefit of consuming beetroot juice as part of a normal diet with regard to lowering blood pressure in normotensive, free-living individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34035 0
Address 34035 0
Country 34035 0
Phone 34035 0
Fax 34035 0
Email 34035 0
Contact person for public queries
Name 17282 0
Prof Peter Clifton
Address 17282 0
GPO Box 664 Adelaide SA 5001
Country 17282 0
Australia
Phone 17282 0
+61884629702
Fax 17282 0
Email 17282 0
[email protected]
Contact person for scientific queries
Name 8210 0
Prof Peter Clifton
Address 8210 0
GPO Box 664 Adelaide SA 5001
Country 8210 0
Australia
Phone 8210 0
+61884629702
Fax 8210 0
Email 8210 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.