Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000381482
Ethics application status
Approved
Date submitted
19/07/2007
Date registered
20/07/2007
Date last updated
20/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Salt, obesity, endothelial function and cardiovascular disease risk study 2007
Scientific title
A 4 week cross-over study investigating the effects of a low salt diet compared to a normal salt diet on blood pressure and vascular function.
Secondary ID [1] 448 0
Commonwealth Scientific Industrial Research Organisation (CSIRO): ad29a
Universal Trial Number (UTN)
Trial acronym
SE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1963 0
Condition category
Condition code
Diet and Nutrition 2061 2061 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
dietary intervention study with a low salt diet (50mmol per day)as the treatment. Volunteers will crossover to both treatments as randomly allocated with no washout between interventions.Participants are on either diet for 2 weeks, then immediately cross-over to the other intervention.
Intervention code [1] 1896 0
Lifestyle
Comparator / control treatment
Normal salt diet (150mmol per day) as the control.
Control group
Active

Outcomes
Primary outcome [1] 3144 0
Flow Mediated Dilatation (FMD): Using an ultrasound machine, we will assess the ability of the upper arm artery to become larger after being blocked with an external blood pressure cuff blown up to 250mm Hg for 5 minutes.
Timepoint [1] 3144 0
Measured at 2 and 4 weeks.
Secondary outcome [1] 4877 0
Blood Pressure
Timepoint [1] 4877 0
Measured at baseline, 2 weeks and 4 weeks.

Eligibility
Key inclusion criteria
• 30 overweight and obese men and women (Body Mass Index 27-40kg/m2)• Systolic blood pressure between 130 and 160 mmHg will be selected. • weight stable over the previous 6 months.
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known metabolic disease such as liver or kidney disease, hypertension systolic Blood pressure>160 mmHg• Cardiovascular disease• Active weight loss in preceding 6 months

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)
Allocation was concealed when it was done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2204 0
Government body
Name [1] 2204 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 2204 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
Country
Australia
Secondary sponsor category [1] 1990 0
Government body
Name [1] 1990 0
Commonwealth Scientific Industrial Research Organisation
Address [1] 1990 0
Country [1] 1990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4006 0
CSIRO Human Nutrition
Ethics committee address [1] 4006 0
Ethics committee country [1] 4006 0
Australia
Date submitted for ethics approval [1] 4006 0
Approval date [1] 4006 0
10/01/2007
Ethics approval number [1] 4006 0
06/32

Summary
Brief summary
The aim of the study is to find out what the effect of a low salt diet compared to a normal salt diet has on blood pressure and vascular function measured by ultra sound in overweight people who are at risk of heart disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27710 0
Address 27710 0
Country 27710 0
Phone 27710 0
Fax 27710 0
Email 27710 0
Contact person for public queries
Name 11085 0
Anne McGuffin
Address 11085 0
CSIRO Human Nutrition
PO Box 10041 (Gate 13 Kintore Ave)
Adelaide BC SA 5000
Country 11085 0
Australia
Phone 11085 0
+61 8 83038988
Fax 11085 0
+61 8 8303 8899
Email 11085 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 2013 0
Jennifer Keogh
Address 2013 0
CSIRO Human Nutrition
PO Box 10041
Gate 13 Kintore Ave
Adelaide BC SA 5000
Country 2013 0
Australia
Phone 2013 0
+61 8303 8907
Fax 2013 0
+61 8 8303 8899
Email 2013 0
jennifer.keogh@csiro.au

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.