Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000124033
Ethics application status
Approved
Date submitted
2/02/2010
Date registered
5/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of dietary salt intake on blood vessel function
Scientific title
Acute effects of dietary salt intake on endothelial function in healthy men and women with normal blood pressure
Secondary ID [1] 1377 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial function 256734 0
Condition category
Condition code
Cardiovascular 256887 256887 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 256888 256888 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised cross-over design, participants will consume a test meal containing 65mmol of sodium or a low salt control meal containing 5mmol sodium on 2 separate study days with a 7 day washout period in between treatments.

The test meal will comprise of 100ml of Reduced Salt tomato soup made up with 150mL water with 3.8g of added salt (65mmol NaCl sodium chloride). Participants are asked to consume the test meal over a 5 minute period.
Intervention code [1] 255952 0
Lifestyle
Intervention code [2] 255953 0
Early detection / Screening
Comparator / control treatment
A control meal containing 5mmol sodium. This will comprise 100mL of Reduced Salt tomato soup made up with 150mL water with no added salt. Participants are asked to consume the test meal over a 5 minute period.
Control group
Dose comparison

Outcomes
Primary outcome [1] 257761 0
Change in endothelial function as measured by flow-mediated dilatation (%)
Timepoint [1] 257761 0
Flow-mediated dilatation is measured at each of the following time points: Baseline (15 minutes before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes
Secondary outcome [1] 263146 0
Change in endothelial function as measured by Reactive Hyperaemia-Peripheral Artery Tonometry (RH-PAT)
Timepoint [1] 263146 0
Baseline (15 minutes before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes
Secondary outcome [2] 263147 0
Change in blood pressure (mmHg) as measured with sphygmomanometer
Timepoint [2] 263147 0
Baseline (15 minutes before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes

Eligibility
Key inclusion criteria
Body Mass Index (BMI) > 18.5 kg/m2
Systolic blood pressure <130mmHg
Diastolic blood pressure <90mmHg
Weight stable over the past 6 months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Know metabolic disease such as liver or kidney disease
Treated hypertension
Previous clinical cardiovascular disease
Use of non-steroidal anti-inflammatory drugs, folate supplementation or systemic steroids
Significant weight loss (>5% body weight) in preceding 6 months
Unable to comprehend study 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)
Central randomisation by computer was carried out by a person indpendent to the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clinstat software is used to generate a randomised sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants receive all the interventions in different sequences during the study. They act as their own control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2521 0
5000

Funding & Sponsors
Funding source category [1] 256453 0
Government body
Name [1] 256453 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO): Food and Nutritional Science
Country [1] 256453 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO): Food and Nutritional Science
Address
Gate 13 Kintore Avenue
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 255761 0
Individual
Name [1] 255761 0
Ms Kacie Dickinson
Address [1] 255761 0
Gate 13 Kintore Avenue
Adelaide SA 5000
Country [1] 255761 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258507 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) : Food and Nutritional Science Human Research Ethics Committee
Ethics committee address [1] 258507 0
Ethics committee country [1] 258507 0
Australia
Date submitted for ethics approval [1] 258507 0
10/11/2009
Approval date [1] 258507 0
17/11/2009
Ethics approval number [1] 258507 0
09/35
Ethics committee name [2] 258508 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 258508 0
Ethics committee country [2] 258508 0
Date submitted for ethics approval [2] 258508 0
17/11/2009
Approval date [2] 258508 0
18/11/2009
Ethics approval number [2] 258508 0
H-179-2009

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

Contacts
Principal investigator
Name 30794 0
Address 30794 0
Country 30794 0
Phone 30794 0
Fax 30794 0
Email 30794 0
Contact person for public queries
Name 14041 0
Ms Kacie Dickinson
Address 14041 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO): Food and Nutritional Science
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 14041 0
Australia
Phone 14041 0
+61 8 8303 8936
Fax 14041 0
+61 8 8303 8899
Email 14041 0
[email protected]
Contact person for scientific queries
Name 4969 0
Ms Kacie Dickinson
Address 4969 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO): Food and Nutritional Science
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 4969 0
Australia
Phone 4969 0
+61 8 8303 8936
Fax 4969 0
+61 8 8303 8899
Email 4969 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.