Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000239460
Ethics application status
Approved
Date submitted
15/02/2016
Date registered
22/02/2016
Date last updated
24/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can increased sodium intake reduce the risk of exercise associated hyponatraemia ?
Scientific title
Can increased sodium intake reduce the risk of exercise associated hyponatraemia in healthy male athletes?
Secondary ID [1] 288540 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exrcise associated hyponatraemia 297642 0
Condition category
Condition code
Diet and Nutrition 297832 297832 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 297842 297842 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will utilise a randomised cross-over intervention in which participants will perform two, 3 h exercise trials (cycle ergometry @ workload to elicit 55% VO2max, determined in a graded maximal exercise test on a separate day) in the heat (34 degrees C, controlled climate chamber), periodically ingesting a beverage, with either 60 or 20 mmol Na+/L and the rate of plasma sodium change monitored. The experimental protocol is based upon earlier work (Vrijens & Rehrer, 1999). The beverages will use a base of Gatorade (5.94% glucose 20 mmol Na+/L ) to which NaCl will be added to bring to 60 mmol Na+/L for intervention beverage. (a pre-trial will be done for acceptability and if unpalatable or gastrointestinal distress a mix of NaCl and sodium citrate will be used). The volume given will be determined by net body mass losses in a 1 h exercise pre-trial conducted on a separate day prior to experimental trials under the same conditions (specified amount of water given). The amount of fluid provided in 3 h experimental trials will be at a rate (given every 15 min) to replace mass loss observed in the 1 h trial (i.e. slight excess since some mass loss is due to substrate metabolism). This will be measured out in advance, chilled and provided to participants who will be told to ingest completely as quickly as possible. No other beverage will be ingested. A researcher will be continually supervising participants during exercise trials. During trials heart rate and rectal temperature will be continually monitored. If age predicted heart rate maximum or a core temperature of 39.5 degrees C is reached exercise will be stopped. Experimental trials will be separated by at least 7 days. The evening before trial 1 litre of sports drink (Gatorade [5.94% glucose 20 mmol Na+/L] provided) will be ingested. Breakfast is to be consumed 2 h before the first experimental trial, which will be of their choice, but they will be required to eat this same meal before the second trial. They will also be instructed to drink 1 L of a sports drink (provided) the evening before each trial. On the day of the trial before coming to the laboratory, they may drink water ad libitum, but may ingest no other foods or fluids after breakfast. In addition, the subjects will be instructed to refrain from strenuous exercise 24 h before each trial.
Intervention code [1] 293918 0
Prevention
Comparator / control treatment
Same exercise and volume of fluid ingestion but with 20 mmol/L sodium in beverage, which is similar to most sports drinks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 297361 0
Change in plasma sodium concentration
Timepoint [1] 297361 0
Baseline prior to exercise and every 30 min thereafter until exercise ceases.
Secondary outcome [1] 320803 0
Change in core temperature, with a rectal thermistor and Squirrel data logger.
Timepoint [1] 320803 0
Measures continually and means per 15 min time period will be calculated across 3 h of exercise or until exhaustion.
Secondary outcome [2] 320804 0
Change in heart rate, with a Polar heart rate monitor which consists of a chest strap and wrist band.
Timepoint [2] 320804 0
Measures continually and means per 15 min time period will be calculated across 3 h of exercise or until exhaustion.
Secondary outcome [3] 320805 0
Ratings of perceived exertion
Timepoint [3] 320805 0
Assessed very 15 min across 3 h of exercise or until exhaustion
Secondary outcome [4] 320806 0
Exercise time (exhaustion) assessed by review of recorded time participant stopped exercising.
Timepoint [4] 320806 0
During 3 h of intended exercise
Secondary outcome [5] 320962 0
Plasma volume change as determined by haemoglobin and haematocrit (Dill & Costill, 1974)
Timepoint [5] 320962 0
At rest, after sitting for 10 min, and every 30 min during exercise for 3 h or until exhaustion.
Secondary outcome [6] 320963 0
Urine sodium output, by volume produced and [Na+] (Flame photomtery).
Timepoint [6] 320963 0
Collected as produced during exercise and immediately following exercise.
Secondary outcome [7] 320964 0
Sweat sodium excretion.
Determined by volume produced (estimated by body mass change corrected for fluid in and urinary output) and sweat [Na+] determined by flame photometry.
Sweat from 4 patches attached on thigh, back, chest and arm..
Timepoint [7] 320964 0
Sweat patches attached at the beginning of exercise and removed after 1 h of exercise.
Body mass measured at the before and at end of exercise.

Eligibility
Key inclusion criteria
Endurance trained males. This does not need to be cycle specific.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers
On prescription medications (except nutritional supplements) or other drug use (except caffeine),
Have kidney disease or diabetes,
Contraindications to participate in maximal exercise.

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)
Beverage prepared by just one staff member sodium content unknown to others, labelled by code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based upon earlier work (Vrijens & Rehrer, 1999) and the rate of plasma sodium change observed, with a similar protocol with ingestion of water versus a typical sports drink with 18 mmol/L sodium, we calculated a sample size of 12 to detect a difference of 1.6 mmol/L/h, with standard deviation of 1.5 mmol/L/h, a=.05, power= .90, for paired samples. A target sample size of 14 will be recruited to allow for drop outs or experiments in which technical error occurs.
Data will be analysed by linear mixed effects model analysis of variance, with time as a fixed effect and subject as a random effect, for data collected over time.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
5/04/2016
Date of last participant enrolment
Anticipated
30/04/2016
Actual
9/01/2017
Date of last data collection
Anticipated
2/02/2017
Actual
Sample size
Target
14
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 7592 0
New Zealand
State/province [1] 7592 0
Otago

Funding & Sponsors
Funding source category [1] 292888 0
University
Name [1] 292888 0
School of Physical Education Sport & Exercise Sciences, University of Otago
Country [1] 292888 0
New Zealand
Primary sponsor type
University
Name
School of Physical Education Sport & Exercise Sciences, University of Otago
Address
PO Box 56, 46 Union ST West
Dunedin 9054 ,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291631 0
None
Name [1] 291631 0
NA
Address [1] 291631 0
NA
Country [1] 291631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294388 0
University of Otago HUman Health Ethical Committee
Ethics committee address [1] 294388 0
c/o Gary Witte, Manager Committees
Registry
PO Box 56
University of Otago
Dunedin 9054
Ethics committee country [1] 294388 0
New Zealand
Date submitted for ethics approval [1] 294388 0
18/12/2015
Approval date [1] 294388 0
15/02/2016
Ethics approval number [1] 294388 0
H16/002

Summary
Brief summary
Exercise associated hyponatraemia is a life threatening condition that can occur in (ultra-) endurance athletes who exercise for long periods of time. The primary risk factor is overhydration with hypotonic fluid, i.e. drinking at a greater rate than any excess can be excreted (Hew-Butler et al 2015). However, other factors can play a role, including sodium losses (Godek, et al 2008) and intakes (Vrijens & Rehrer, 1999). Although ingesting a beverage with 18 mmol/L sodium reduces the rate of decline in plasma sodium when compared with water (during endurance exercise in the heat) it still does decline. Sweat sodium ranges from ~30-80 mmol/L and studies with 60 mmol/L sodium (oral rehydration solutions) in clinical situations (at rest), in which plasma sodium is compromised via losses, result in improved hydration and normalisation of plasma sodium. Therefore, we intend to test the efficacy of a beverage with 60 mmol/L sodium, when consumed in slight excess (i.e. approximately matching body mass loss) throughout longlasting exercise in the heat (34 degrees C) in healthy, endurance trained individuals. The purpose of this study is to establish whether increasing the concentration of sodium in a beverage (~ 3 times that normally in sports drinks), can keep blood sodium concentration from decreasing during longlasting exercise in the heat, when fluid is ingested in amounts to nearly match body weight loss.
The hypothesis is that ingesting a beverage with 60 mmol/L of sodium during 3 h of cycling in the heat will prevent the fall in blood sodium that typically occurs with a beverage with 18-20 mmol/L of sodium. We will utilise a randomised cross-over intervention in which participants will perform exercise in the heat, and will ingest a beverage with one of two concentrations of sodium (20, 60 mmol/L) and then repeat the trial with the alternate concentration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63554 0
A/Prof Nancy J Rehrer
Address 63554 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56, 46 Union St West
Dunedin 9054
Country 63554 0
New Zealand
Phone 63554 0
+6434799128
Fax 63554 0
Email 63554 0
[email protected]
Contact person for public queries
Name 63555 0
Nancy J Rehrer
Address 63555 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56, 46 Union St West
Dunedin 9054
Country 63555 0
New Zealand
Phone 63555 0
+6434799128
Fax 63555 0
Email 63555 0
[email protected]
Contact person for scientific queries
Name 63556 0
Nancy J Rehrer
Address 63556 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56, 46 Union St West
Dunedin 9054
Country 63556 0
New Zealand
Phone 63556 0
+6434799128
Fax 63556 0
Email 63556 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4588Conference abstractNo Rehrer NJ, Wijering L, Cotter JD. Can Increased So... [More Details] 370124-(Uploaded-27-12-2018-05-54-01)-Other results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomized, cross-over trial assessing effects of beverage sodium concentration on plasma sodium concentration and plasma volume during prolonged exercise in the heat2022https://doi.org/10.1007/s00421-022-05025-y
N.B. These documents automatically identified may not have been verified by the study sponsor.