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Trial registered on ANZCTR


Registration number
ACTRN12613001373763
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
13/12/2013
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a starch-based oral rehydration solution in dehydration following training in Australian Rules footballers.
Scientific title
Effect of a starch-based oral rehydration solution in dehydration following training on recovery in Australian Rules footballers.
Secondary ID [1] 283560 0
None
Secondary ID [2] 289066 0
nil
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dehydration in ellite athletes following intensive training sessions 290466 0
Condition category
Condition code
Diet and Nutrition 290858 290858 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral rehydration solution (Sports-FS-ORS or SpORS) contains a balance of salts, glucose, and starches which optimise water absorption by being hypo-osmolar and by also utilising the absorptive capacity of the large intestine.
Intervention code [1] 288256 0
Lifestyle
Intervention code [2] 288420 0
Prevention
Comparator / control treatment
the control/comparator treatment is "usual care" or "standard practice" for the football players during training sessions
Control group
Active

Outcomes
Primary outcome [1] 290980 0
To improve player recovery from heavy exertion
this will be assessed by;
Body weight
Urine; specific gravity
Haematocrit;
Visual Analog Scale to address: thirst, bloatedness, refreshed, stomach upset and tiredness (Kalman et. al., 2012).
Timepoint [1] 290980 0
Baseline will be assessed;
Just prior to commencing the training session

Post training will be assessed:
When leaving the training field
1hour later after warm-down.
Primary outcome [2] 291085 0
To improve player on-field performance since it will maintain blood volume and muscle flow
This will be assessed by;
Body weight
Urine; specific gravity
Haematocrit;
Visual Analog Scale to address: thirst, bloatedness, refreshed, stomach upset and tiredness (Kalman et. al., 2012).
Timepoint [2] 291085 0
Baseline will be assessed;
Just prior to commencing the training session

Post training will be assessed:
When leaving the training field
1hour later after warm-down.
Secondary outcome [1] 305733 0
To enable players to be better prepared for the next event.
This will be assessed by;
Body weight
Urine; specific gravity
Haematocrit;
Visual Analog Scale to address: thirst, bloatedness, refreshed, stomach upset and tiredness (Kalman et. al., 2012).
Timepoint [1] 305733 0
Baseline will be assessed;
Just prior to commencing the training session

Post training will be assessed:
When leaving the training field
1hour later after warm-down.

Eligibility
Key inclusion criteria
Professional football players aged between 18-35 years Willing to participate. Not vomiting and considered (by the player) to be able to tolerate the anticipated fluid intake. No current GI disorder.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Receiving diuretics or other drugs considered likely to affect hydration.
Unwilling/unable to sign the study consent form
Unwilling to participate in any or some of the stated procedures required of the study
Any known allergies to the proposed study intervention products

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
This will be a cross-over study where all participants will cross between one week of "usual care"and the intervention during three intensive training sessions'
Participants will be allocated to the different treatment order with a randomised player number selection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regarding power and group sizes, the paper by Kalman et.al 2012 provides guidance as to variance.
With regard to body weight, a difference between treatments either at the end of the session or following the warm-down, of 1kg (corresponding to 1L) would seem worthwhile. Given the expected variance, a sample size of 34 will have 80% power to detect a difference in means of 1.0 (e.g. a First condition mean of 78.0 kg and a Second condition mean of 79.0 kg), assuming a standard deviation of differences of 2.0, using a paired t-test with a 0.050 two-sided significance level.

The results are almost identical for urine specific gravity. A sample size of 34 will have 80% power to detect a difference in means of 0.01 (e.g. a First condition mean of 1.02 and a Second condition mean of 1.03), assuming a standard deviation of differences of 0.02, using a paired t-test with a 0.050 two-sided significance level.
Reference
Kalman, DS, Feldman, S, Krieger, DR and Bloomer, RJ. Comparison of coconut water and a carbohydrate-electrolyte sport drink on measures of hydration and physical performance in exercise-trained men. Journal of the International Society of Sports Nutrition, 2012, 9 (1).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2014
Actual
13/01/2014
Date of last participant enrolment
Anticipated
Actual
31/01/2014
Date of last data collection
Anticipated
Actual
31/01/2014
Sample size
Target
35
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7616 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 288336 0
Other Collaborative groups
Name [1] 288336 0
Flinders Partners Pty Ltd
Country [1] 288336 0
Australia
Primary sponsor type
Individual
Name
Professor Graeme P Young
Address
ACRF Cancer Prevention Unit, FCIC,
Flinders University
1 Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 287052 0
Other Collaborative groups
Name [1] 287052 0
Flinders Partners Pty Ltd
Address [1] 287052 0
Mark Oliphant Building
Laffer Drive, Science Park Adelaide
Bedford Park SA 5042
Country [1] 287052 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290270 0
Southern Adelaide Clinican Human Research Ethics Committee
Ethics committee address [1] 290270 0
Flinders Medical Centre, The Flats G5 - Rooms 3 & 4, Flinders Drive, Bedford Park, SA 5042
Ethics committee country [1] 290270 0
Australia
Date submitted for ethics approval [1] 290270 0
21/10/2013
Approval date [1] 290270 0
05/12/2013
Ethics approval number [1] 290270 0
465.13/HREC/13/SAC/366

Summary
Brief summary
1.Background:
Dehydration, or the loss of fluid and salt from the body can sometimes be a life-threatening disorder. Intense exercise can cause the loss of 1-3L of fluid/h and may be aggravated by warm climates (Ramakrishna, 2004). The fluid deficit typically ranges from 2-4% of body weight and can result in thermal stress, impaired cognition and cardiovascular function, accelerated fatigue and impaired exercise function (Rodriguez et al., 2009). During an Australian Rules football game or intensive training session AFL players lose between 1.15-3.45% of their body weight. As outlined above this degree of fluid loss will result in physiological changes that impact on player performance. The current sports drinks consumed by players during and after the game have a high glucose content much higher than in proven rehydration solutions. Because of the high glucose content (hyperosmolar to body fluids) it is inefficient for hydration, leads to a slower than achievable water absorption and only utilises the absorptive capacity of the small intestine and not the large intestine. It has been shown that hypo-osmolar solutions achieve faster and more effective rehydration in children and adults with acute diarrhoea and as a consequence, hypo-osmolar solutions are the WHO/UNICEF policy for rehydration [WHO/UNICEF, 2009]
Oral rehydration solutions which utilise the absorptive capacity of both the large and small intestine have been developed and proven effective in the treatment of cholera. Water and salt absorption through the large intestine requires the presence of short chain fatty acids (SCFAs) which are fermented by colonic bacteria from carbohydrates
This study aims to build on this foundation work and test a formulation that is designed for healthy guts taking advantage of absorption of fluids and salts from the large and small intestine.
2.Rationale:
The current sports (“hydration”) drinks are really energy drinks because they have a high glucose content are designed less for rehydration than they are for delivering glucose. As such they seem to be less than ideal for rehydration when dehydration is evident
Provision of “resistant starch” will do this while at the same time providing glucose in the small intestine. It is thus conceived as a dual-action solution providing glucose to stimulate small intestinal uptake and RS for fermentation to SCFA to drive large intestine uptake. This principle has been tested now in four randomised controlled trials in India in severe acute diarrhoea and in all studies it reduces severity of diarrhoea significantly.
This study will test whether the use of RS and an oral rehydration solution (Sports-FS-ORS or SpORS), which contains a balance of salts, glucose, and starches which optimise water absorption by also utilising the absorptive capacity of the large intestine, can improve hydration in elite athletes during and after strenuous exercise.
Trial website
n/a
Trial related presentations / publications
publications are in progress , no citations as yet
Public notes

Contacts
Principal investigator
Name 44190 0
Prof Graeme P Young MB BS MD FCRACP FTSE AGAF
Address 44190 0
ACRF Cancer Prevention Unit, FCIC,
Flinders University
1Flinders Drive
Bedford Park
SA 5042
Country 44190 0
Australia
Phone 44190 0
+61 8 8404 2841
Fax 44190 0
Email 44190 0
graeme.young@flinders.edu.au
Contact person for public queries
Name 44191 0
Dr Sinead O'Connell
Address 44191 0
Flinders Partners Pty Ltd
Box 9, Mark Oliphant Building
Laffer Drive, Science Park Adelaide
Bedford Park SA 5042
Country 44191 0
Australia
Phone 44191 0
+61 (0) 8 8201 7716
Fax 44191 0
+61 (0) 8 8201 7888
Email 44191 0
sinead.oconnell@flinderspartners.com
Contact person for scientific queries
Name 44192 0
Prof Graeme P Young MB BS MD FCRACP FTSE AGAF
Address 44192 0
ACRF Cancer Prevention Unit, FCIC,
Flinders University
1 Flinders Drive
Bedford Park
SA 5042
Country 44192 0
Australia
Phone 44192 0
+61 8 8404 2841
Fax 44192 0
Email 44192 0
graeme.young@flinders.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseComparison of a sports-hydration drink containing high amylose starch with usual hydration practice in Australian rules footballers during intense summer training.2018https://dx.doi.org/10.1186/s12970-018-0253-8
N.B. These documents automatically identified may not have been verified by the study sponsor.