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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood pressure and salt intake: Translating the benefits of salt reduction into practice
Scientific title
A randomised parallel study to assess the effect of dietary education about salt intake compared with usual care in individuals with hypertension who have lost weight following laparoscopic adjustable gastric banding.
Secondary ID [1] 262180 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 265861 0
Condition category
Condition code
Diet and Nutrition 266017 266017 0 0
Other diet and nutrition disorders
Cardiovascular 266021 266021 0 0

Study type
Description of intervention(s) / exposure
Usual salt intake in overweight and obese people is approximately 11 g salt/day in men and 8 g salt/day in women which is much higher than the NHMRC population target of 6g salt/day. In this study patients will be educated to reduce their salt intake using the simple strategy to choose foods defined according to the Food Standards Australia and New Zealand (FSANZ) guideline of 120 mg sodium/100g food. They will also be given general guidelines regarding reducing sodium intake. This advice will be given on an individual basis by a dietitian at the start of the study and participants will have access to the dietitian for advice and support regarding dietary changes throughout the study. Interventions will require three visits of about 30 minutes duration at the start of the study, and at three and six months, where blood pressure will be taken and height and weight measured. A 24 hour urine sample will also be collected on each occasion. Compliance will be assessed by sodium excretion measurement.
Intervention code [1] 264585 0
Treatment: Other
Intervention code [2] 264588 0
Intervention code [3] 264590 0
Comparator / control treatment
This is a randomised parallel study of two groups - salt reduction to a target 100mmol Na/day (approximately 6g salt/day) compared with usual care. Usual care is defined as dietary education with no specific advice on sodium reduction. At the end of the study patients in the usual care arm will be given the same information about reducing salt intake as the intervention arm.
Control group

Primary outcome [1] 266758 0
Blood Pressure measured by automated sphygmomanometer (mean of three measurements)
Timepoint [1] 266758 0
Baseline, three and six months
Secondary outcome [1] 276330 0
24 hour urinary sodium and potassium excretion
Timepoint [1] 276330 0
Baseline, three and six months
Secondary outcome [2] 276331 0
Weight measured by weighing scales
Timepoint [2] 276331 0
Baseline, three and six months

Key inclusion criteria
People who have lost weight following laparoscopic adjustable gastric banding who have hypertension
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Subjects with known metabolic disease such as liver or kidney disease. Use of non-steroidal anti-inflammatory drugs because of their effect on sodium retention.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be invited to participate in the study and provided with written information. Following their consent they will be randomised to either usual care or sodium reduction. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using a computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267081 0
Other Collaborative groups
Name [1] 267081 0
Australian Institute of Weight Control
Address [1] 267081 0
St. Joseph's Cottage
Calvary Hospital
89 Strangways Tce
North Adelaide, SA 5006
Country [1] 267081 0
Funding source category [2] 267087 0
Other Collaborative groups
Name [2] 267087 0
Baker IDI
Address [2] 267087 0
Level 3, 193-195 North Terrace
Adelaide, SA 5000
Country [2] 267087 0
Primary sponsor type
Other Collaborative groups
Baker IDI
Level 3, 193-195 North Terrace
Adelaide, SA 5000
Secondary sponsor category [1] 264175 0
Name [1] 264175 0
Address [1] 264175 0
Country [1] 264175 0

Ethics approval
Ethics application status
Ethics committee name [1] 267061 0
Alfred Hospital
Ethics committee address [1] 267061 0
The Alfred
P.O Box 315
Prahran. Vic. 3181.
Ethics committee country [1] 267061 0
Date submitted for ethics approval [1] 267061 0
Approval date [1] 267061 0
Ethics approval number [1] 267061 0

Brief summary
A high salt intake is a neglected risk factor for heart disease and stroke. Recently attention has been drawn to the potential reduction in death and disease a decrease of 3g salt/day can bring. The aim of this study is to translate knowledge into practice by substantiating dietetic practice in salt reduction in individuals with hypertension at increased risk of cardiovascular disease. Cardiovascular disease is a significant burdens for individuals and for the Australian health care system potentially leading to early death or disability. Keeping blood pressure well controlled has a key role in the prevention of cardiovascular disease.
Salt reduction can greatly assist blood pressure control but there are no studies evaluating the most effective education strategies to help people with hypertension implement and maintain salt reduction. This study will help fill this gap. The expected outcomes are that a lower salt intake of 6g/day is sustainable and will reduce blood pressure by 3-5mmHg SBP/day.
Trial website
Trial related presentations / publications
Ireland DM, Clifton PM, Keogh JB. Achieving the salt intake target of 6 g/day in the current food supply in free-living adults using two dietary education strategies. J Am Diet Assoc. 2010 May;110(5):763-7.
Public notes

Principal investigator
Name 32612 0
Address 32612 0
Country 32612 0
Phone 32612 0
Fax 32612 0
Email 32612 0
Contact person for public queries
Name 15859 0
Dr. Jennifer Keogh
Address 15859 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide, SA 5000
Country 15859 0
Phone 15859 0
+61 8 8302 2579
Fax 15859 0
Email 15859 0
Contact person for scientific queries
Name 6787 0
Dr. Jennifer Keogh
Address 6787 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471
Adelaide, SA 5000
Country 6787 0
Phone 6787 0
+61 8 8302 2579
Fax 6787 0
Email 6787 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results