Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

082159

ACTR Number:

ACTRN12607000381482

Trial Status:

Registered

Date Submitted:

19/07/2007

Date Registered:

20/07/2007

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Public title:

Salt, obesity, endothelial function and cardiovascular disease risk study 2007

ANZCTR registration 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:

Commonwealth Scientific Industrial Research Organisation (CSIRO): ad29a

UTN:

Trial acronym:

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Health condition(s) or problem(s) studied:
Obesity

Diet and nutrition	Obesity
Condition category:	Condition code:

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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:

Lifestyle

Comparator / control treatment:

Normal salt diet (150mmol per day) as the control.

Control group:

Active

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Primary outcome:	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:	Measured at 2 and 4 weeks.
Secondary outcome:	Blood Pressure
Timepoint:	Measured at baseline, 2 weeks and 4 weeks.

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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

Gender:

Both males and females

Healthy volunteers?

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

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Study type:

Interventional

Purpose of the study:

Treatment

Allocation to intervention:

Randomised controlled trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Allocation was concealed when it was done by central randomisation by computer

Describe the 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)

Assignment:

Crossover

Other design features (specify):

Type of endpoint(s):

Efficacy

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Phase

Phase 4

Anticipated or actual date of first participant enrolement:

8/10/2007

Target sample size:

Recruitment status:

Not yet recruiting

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Funding source:

Government funding body e.g. Australian Research Council

Name:

Commonwealth Scientific Industrial Research Organisation

Address:

Country:

Australia

Primary sponsor:

Government funding body e.g. Department of Health

Name:

Commonwealth Scientific Industrial Research Organisation

Address:

Country:

Australia

Secondary sponsor:

Government funding body e.g. Department of Health

Name:

Commonwealth Scientific Industrial Research Organisation

Address:

Country:

Australia

Other collaborator:

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Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

CSIRO Human Nutrition

Address:

Country:

Australia

Date of approval:

10/01/2007

HREC Number:

06/32

Countries of recruitment:

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:

Presentations / publication list:

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Contact person for public queries

Name:

Anne McGuffin

Address:

CSIRO Human Nutrition PO Box 10041 (Gate 13 Kintore Ave) Adelaide BC SA 5000

Country:

Australia

Tel:

+61 8 83038988

Fax:

+61 8 8303 8899

Email:

anne.mcguffin@csiro.au

Contact person for scientific queries

Name:

Jennifer Keogh

Address:

CSIRO Human Nutrition PO Box 10041 Gate 13 Kintore Ave Adelaide BC SA 5000

Country:

Australia

Tel:

+61 8303 8907

Fax:

+61 8 8303 8899

Email:

jennifer.keogh@csiro.au

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

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