Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000439943
Ethics application status
Approved
Date submitted
27/04/2011
Date registered
28/04/2011
Date last updated
2/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute effect of sodium and potassium intake on brachial blood pressure, central blood pressure and blood vessel function.
Scientific title
Acute effect of sodium and potassium intake on brachial blood pressure, central blood pressure and blood vessel function: a randomised, crossover study in healthy individuals
Secondary ID [1] 260063 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 265731 0
Condition category
Condition code
Cardiovascular 265869 265869 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Low Sodium [low in sodium (~500mg) and low in Potassium (~500mg)]
2. High Potassium [low in sodium (~500mg) and high in Potassium (~1500mg)]

This study involves comparing the effects of three meals comprising of meat and bread (containing different amounts of sodium and potassium) on brachial and central bloodpressure.
Washout of at least 72 hours between test days.
Measures will be collected every fifteen minutes for three hours postprandially and comparisons will be made between the control and intervention meals for their effects on blood pressure and measures of blood vessel function.
Intervention code [1] 264480 0
Lifestyle
Intervention code [2] 264483 0
Prevention
Comparator / control treatment
Control meal – [moderately high sodium (~1500mg) and low potassium (~500mg)]
Control group
Active

Outcomes
Primary outcome [1] 266636 0
brachial and central blood pressure measured with pulse wave analysis (PWA) technique
Timepoint [1] 266636 0
fasting (immediately prior to the meal) and then every fifteen minutes to upto three hours post meal intake
Secondary outcome [1] 276119 0
Augmentation index - a measure of blood vessel function, measured with PWA technique
Timepoint [1] 276119 0
fasting (immediately prior to the meal) and then every fifteen minutes to upto three hours post meal intake

Eligibility
Key inclusion criteria
Age: 30 - 70 years
Brachial blood pressure: systolic <150 mmHg; diastolic <95 mmHg
No history of renal disease
No diabetes, liver disease or other heart conditions
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have gluten intolerance
Do not eat red meat
Have had recent changes in blood pressure medication
Are taking medications that may interact with potassium e.g. ACE-Inhibitors

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation - computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264955 0
University
Name [1] 264955 0
University of Tasmania
Country [1] 264955 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Locked Bag 1320,
School of Human Life Sciences,
UTAS, Launceston 7250
Country
Australia
Secondary sponsor category [1] 264052 0
None
Name [1] 264052 0
Address [1] 264052 0
Country [1] 264052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266915 0
Human Reseach Ethics committee (Tasmania) Network
Ethics committee address [1] 266915 0
Ethics committee country [1] 266915 0
Australia
Date submitted for ethics approval [1] 266915 0
Approval date [1] 266915 0
05/01/2011
Ethics approval number [1] 266915 0
H11505

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

Contacts
Principal investigator
Name 32537 0
Address 32537 0
Country 32537 0
Phone 32537 0
Fax 32537 0
Email 32537 0
Contact person for public queries
Name 15784 0
Dr Kiran Ahuja
Address 15784 0
Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250
Country 15784 0
Australia
Phone 15784 0
+61 3 6324 5478
Fax 15784 0
Email 15784 0
[email protected]
Contact person for scientific queries
Name 6712 0
Dr Kiran Ahuja
Address 6712 0
Locked Bag 1320, School of Human Life Sciences,
University of Tasmania,
Launceston 7250
Country 6712 0
Australia
Phone 6712 0
+61 3 6324 5478
Fax 6712 0
Email 6712 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.