Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000939897
Ethics application status
Approved
Date submitted
22/08/2012
Date registered
4/09/2012
Date last updated
8/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary salt and responses to fluid overload during exercise
Scientific title
High versus low sodium diet and effects on urinary excretion and plasma sodium concentration during exercise with fluid overload in healthy active individuals.
Secondary ID [1] 281085 0
Nil
Universal Trial Number (UTN)
U1111-1133-5656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise associated hyponatraemia 287224 0
Condition category
Condition code
Diet and Nutrition 287549 287549 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of 10 days on either a “normal western “, i.e. High salt diet, vs. 10 days on a Low salt diet. Participants will be given a pamphlet in which foods to reduce intake of will be listed and cooking advice will be given prior to commencing the Low salt diet to reduce the dietary salt intake on their own accord. For the High salt diet participants will simply be asked to maintain their normal dietary habits. Participants will fill in a food frequency questionnaire (FFQ) on both diets. The FFQ is being validated at present and the low salt pamphlet developed with New Zealand product examples. On days 7-9 total urinary output will be collected to monitor Na+ output as a measure of intake.
There will be at least 10 days "wash-out" period between two diets. Participants will be able to do their own exercise training (noted in a diary) during the dietary interventions but no exercise on day 9 and on day 10 of each diet they will conduct a 3 hour exercise (cycling or running at 55% VO2max) trial in the heat (34 degrees C) laboratory (supervised by the researchers) in which blood and urine samples will be taken.
Intervention code [1] 285531 0
Lifestyle
Comparator / control treatment
High salt diet= normal diet
Control group
Dose comparison

Outcomes
Primary outcome [1] 287796 0
Plasma sodium concentration
Timepoint [1] 287796 0
On day 10 of diet, during 3 hours of (cycle or running) exercise in the heat at 0, 15 minutes and every 30 minutes thereafter.
Primary outcome [2] 287797 0
Urinary excretion (volume and Na+)
Timepoint [2] 287797 0
Day 10
Cumulative urine production during the exercise trial: during the exercise itself, if and when the participant feels the need to urinate, and then immediately following the 3 hour exercise trial.
Secondary outcome [1] 298849 0
Resting blood pressure
This will be measured, in the fasted state, participants having sat for 10 minutes with arm supported, legs uncrossed, with an automated sphygmomanometer. Two measurements will be made and if they are not similar a third measurement will be made. An average of the two (closest) will be taken.
Timepoint [1] 298849 0
Morning day 1 before starting dietary intervention and on day 10 of dietary intervention, prior to exercise trial.

Eligibility
Key inclusion criteria
Endurance trained in running or cycling.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The presence of kidney disease, hypertension and on any medication or supplements other than multivitamins or sports drinks.

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)
Volunteers.
Complete cross-over (all subjects do both treatments, with a 10 or more day wash-out in between), randomised order.
The allocation order will be known to researchers and to participants; however, plasma and urine samples will be coded by a separate technician who will not conduct the analyses and thus the results will not be known until the analyses are completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table for treatment order
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
3/11/2014
Date of last participant enrolment
Anticipated
Actual
22/01/2015
Date of last data collection
Anticipated
Actual
12/02/2015
Sample size
Target
12
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 4499 0
New Zealand
State/province [1] 4499 0
Otago

Funding & Sponsors
Funding source category [1] 285860 0
University
Name [1] 285860 0
School of Physical Education , University of Otago PBRF funding
Country [1] 285860 0
New Zealand
Primary sponsor type
University
Name
School of Physical Education , University of Otago PBRF funding
Address
PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284680 0
None
Name [1] 284680 0
Address [1] 284680 0
Country [1] 284680 0
Other collaborator category [1] 277033 0
University
Name [1] 277033 0
Dr Jim Cotter
Address [1] 277033 0
School of Physical Education, Sport & Exercise Sciences, University of Otago PO Box 56 Dunedin 9054
Country [1] 277033 0
New Zealand
Other collaborator category [2] 278712 0
Individual
Name [2] 278712 0
Prof Simon Thornton
Address [2] 278712 0
Universite de Lorraine,

U 1116 UL-INSERM
Defiance cardiovasculaire, aigue et chronique
Bat. D, 1er etage
Faculte de Medecine
9, Avenue de la foret de Haye,
CS 50184 - 54505 VANDŒUVRE Les Nancy cedex
France
Country [2] 278712 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287885 0
Human Ethics Committee University of Otago, Academic Committees
Ethics committee address [1] 287885 0
Ethics committee country [1] 287885 0
New Zealand
Date submitted for ethics approval [1] 287885 0
Approval date [1] 287885 0
18/06/2012
Ethics approval number [1] 287885 0
1/12/0122

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

Contacts
Principal investigator
Name 34605 0
A/Prof Nancy J Rehrer
Address 34605 0
School of Physical Education, Sport & Exercise Sciences, Otago University, PO Box 56, Dunedin 9054
Country 34605 0
New Zealand
Phone 34605 0
+6434799128
Fax 34605 0
Email 34605 0
[email protected]
Contact person for public queries
Name 17852 0
Dr Nancy J Rehrer
Address 17852 0
School of Physical Education, Otago University, PO Box 56, Dunedin 9054
Country 17852 0
New Zealand
Phone 17852 0
+6434799128
Fax 17852 0
+6434798309
Email 17852 0
[email protected]
Contact person for scientific queries
Name 8780 0
Dr Nancy J Rehrer
Address 8780 0
School of Physical Education, Otago University, PO Box 56, Dunedin 9054
Country 8780 0
New Zealand
Phone 8780 0
+6434799128
Fax 8780 0
+6434798309
Email 8780 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.