Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000822886
Ethics application status
Approved
Date submitted
18/07/2012
Date registered
6/08/2012
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a high potassium diet on endothelial function
Scientific title
Effect of a high potassium diet on endothelial function of healthy persons
Secondary ID [1] 280869 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 286940 0
Condition category
Condition code
Diet and Nutrition 287274 287274 0 0
Other diet and nutrition disorders
Cardiovascular 287275 287275 0 0
Coronary heart disease
Cardiovascular 287276 287276 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised crossover study of a 1week diet high in potassium (5690mg or 150mmol/day) versus a 1 week usual potassium (3110mg or 80mmol/day) diet with no washout between diets. Dietary targets are acheived by substituting serves of pasta/rice with serves of potatoes and apples with bananas each day.
Intervention code [1] 285302 0
Prevention
Intervention code [2] 285417 0
Lifestyle
Comparator / control treatment
1 week of usual potassium (3110mg or 80mmol/day) diet
Control group
Active

Outcomes
Primary outcome [1] 287551 0
Brachial artery flow meadiated dilatation (FMD) - percentage of dilatation
Timepoint [1] 287551 0
Measured on completion of each dietary intervention only
Secondary outcome [1] 298368 0
nil
Timepoint [1] 298368 0
nil

Eligibility
Key inclusion criteria
BMI greater than 18kg/m2 and less than 30kg/m2 SBP <130mmHg DBP<90mmHg weight stable for 6months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of antihypertensive medication, systemic steroids, folate supplementation or non-steroidal antiinflammatory
drugs.
Metabolic disease such as liver or kidney disease.
Treated hypertension.
Previous clinical cardiovascular disease.
Unable to comprehend protocol.

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)
The study will be advertised publicly. Participants will be enrolled and randomised to treatment order after screening using an online generated balanced random number allocation sequence (randomization.com) by a person independent to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants are assigned treatment order using a numbered random-allocation sequence generated by using an online generated balanced random number allocation sequence (randomization.com) by a person independent to the study.
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
30/08/2012
Actual
12/03/2013
Date of last participant enrolment
Anticipated
Actual
27/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285653 0
University
Name [1] 285653 0
University of South Australia
Country [1] 285653 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284490 0
None
Name [1] 284490 0
Address [1] 284490 0
Country [1] 284490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287650 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 287650 0
Ethics committee country [1] 287650 0
Australia
Date submitted for ethics approval [1] 287650 0
29/05/2012
Approval date [1] 287650 0
18/07/2012
Ethics approval number [1] 287650 0
0000029701

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

Contacts
Principal investigator
Name 34453 0
A/Prof Associate Professor Jennifer Keogh
Address 34453 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 34453 0
Australia
Phone 34453 0
+61 8 8302 2579
Fax 34453 0
Email 34453 0
[email protected]
Contact person for public queries
Name 17700 0
Associate Professor Jennifer Keogh
Address 17700 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 17700 0
Australia
Phone 17700 0
+61 8 8302 2579
Fax 17700 0
Email 17700 0
[email protected]
Contact person for scientific queries
Name 8628 0
Associate Professor Jennifer Keogh
Address 8628 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 8628 0
Australia
Phone 8628 0
+61 8 8302 2579
Fax 8628 0
Email 8628 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
SourceTitleYear of PublicationDOI
EmbaseEffect of high potassium diet on endothelial function.2014https://dx.doi.org/10.1016/j.numecd.2014.04.009
N.B. These documents automatically identified may not have been verified by the study sponsor.