Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000583943
Ethics application status
Approved
Date submitted
3/06/2011
Date registered
6/06/2011
Date last updated
28/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary salt and blood vessel function
Scientific title
The effect of a high sodium meal versus a low sodium meal on acute blood vessel function in healthy volunteers: a randomised crossover trial
Secondary ID [1] 262308 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial function 268018 0
Condition category
Condition code
Cardiovascular 268147 268147 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 268148 268148 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] 266702 0
Lifestyle
Intervention code [2] 266703 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. Participants will act as their own controls as it is a cross-over
Control group
Dose comparison

Outcomes
Primary outcome [1] 266896 0
Change in plasma electrolytes. Blood samples will be analysed by a certified commercial laboratory.
Change in plasma nitrate/nitrite will be measured using a commercially available enzyme-linked immunoassay (ELISA) kit.
Timepoint [1] 266896 0
Blood biomarkers are measured at each of the following time points: Baseline (immediately before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes
Primary outcome [2] 266897 0
Change in plasma ADH, ANP, osmolality and osmolarity
Timepoint [2] 266897 0
Blood biomarkers are measured at each of the following time points: Baseline (immediately before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes
Secondary outcome [1] 276580 0
Thirst will be measured using a visual analogue scale
Timepoint [1] 276580 0
Thirst will be measured at each of the following time points: Baseline (immediately before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes
Secondary outcome [2] 298950 0
Change in vascular function as measured by Augmentation Index (AIx)
Timepoint [2] 298950 0
Augmentation index is measured at each of the following time points: Baseline (immediately before test meal consumption); post meal consumption at 30minutes; 60minutes; 90minutes; 120minutes

Eligibility
Key inclusion criteria
Male or female aged 18-70
BMI <28kg/m2 and > 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
Recruiting
Date of first participant enrolment
Anticipated
6/06/2011
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] 4068 0
5000

Funding & Sponsors
Funding source category [1] 267187 0
Government body
Name [1] 267187 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO): Food and Nutritional Science
Country [1] 267187 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] 266261 0
University
Name [1] 266261 0
University of Adelaide
Address [1] 266261 0
Discipline of Physiology
North Terrace Campus
Adelaide SA 5000
Country [1] 266261 0
Australia
Other collaborator category [1] 252038 0
Individual
Name [1] 252038 0
Professor Louise Burrell
Address [1] 252038 0
Heidelberg Repatriation Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 252038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269180 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) : Food and Nutritional Science Human Research Ethics Committee
Ethics committee address [1] 269180 0
Ethics committee country [1] 269180 0
Australia
Date submitted for ethics approval [1] 269180 0
Approval date [1] 269180 0
29/04/2011
Ethics approval number [1] 269180 0
11/05/2011
Ethics committee name [2] 269181 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 269181 0
Ethics committee country [2] 269181 0
Australia
Date submitted for ethics approval [2] 269181 0
Approval date [2] 269181 0
20/04/2011
Ethics approval number [2] 269181 0
H-033-2011

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

Contacts
Principal investigator
Name 32697 0
Address 32697 0
Country 32697 0
Phone 32697 0
Fax 32697 0
Email 32697 0
Contact person for public queries
Name 15944 0
Dr Jennifer Keogh
Address 15944 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471 Adelaide SA 5000
Country 15944 0
Australia
Phone 15944 0
+61 8 8302 2579
Fax 15944 0
+61 8 8302 2389
Email 15944 0
[email protected]
Contact person for scientific queries
Name 6872 0
Dr Jennifer Keogh
Address 6872 0
University of South Australia
School of Pharmacy and Medical Sciences
GPO Box 2471 Adelaide SA 5000
Country 6872 0
Australia
Phone 6872 0
+61 8 8302 2579
Fax 6872 0
+61 8 8302 2389
Email 6872 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.