Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001128684
Ethics application status
Approved
Date submitted
29/09/2023
Date registered
1/11/2023
Date last updated
1/11/2023
Date data sharing statement initially provided
1/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Sports-Hydration Drink on Infantry Soldiers
Scientific title
Effects of a Sports-Hydration Drink Containing High Amylose Maize Starch on the Hydration Status of Infantry Soldiers: a randomised cross-over trial
Secondary ID [1] 310411 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dehydration 331167 0
Condition category
Condition code
Diet and Nutrition 327939 327939 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised cross over design was employed.
Phase 1 (4 days)
Group A participants received the active treatment (EXP) while Group B followed their usual hydration practices (CON). Usual hydration practices consisted of unrestricted access to plain water and the availability of hot beverages (e.g. tea and coffee), fruit juices and flavored water at the messing facility during meal times.

Phase 2 (3 days)
No active treatment employed.

Phase 3 (4 days)
Group B received the active treatment (EXP) while Group A followed their usual hydration practices (CON).

Intervention (EXP treatment)
Participants were given a beverage the night before each training mission and instructed to drink the “preparation beverage” at least 6 hours before training the next day. The preparation beverage was 350 mL of PREPD Hydration® Prime (PREPD Hydration, Adelaide Australia) containing 34 g of High Amylose Maize Starch (HAMS) and was consumed on days 1 and 3 of study Phase 1; and days 8 and 10 of study Phase 3.
At least 30 minutes after the end of the training mission, participants were instructed to drink the “recovery beverage”, specifically 700 mL beverages of PREPD Hydration® Recover containing 34 g of HAMS. The recovery beverage was consumed on days 2 and 4 of study Phase 1; and days 9 and 11 of study Phase 3.
Beverages were consumed under observation by a team of military nutrition researchers with over 20 years experience conducting research with the Australian Defence Force. All beverage containers were returned to the researchers for weighing to estimate the amounts consumed and compliance with the EXP treatment.
The beverages provided to participants are commercially available (PREPD Hydration, Adelaide, Australia). They do not contain any allergens and are certified by Human and Supplement Testing Australia (HASTA), having been tested by the manufacturers for over 200 World Anti-Doping Agency (WADA) banned substances.
Intervention code [1] 326810 0
Lifestyle
Comparator / control treatment
An active control was used in this study where study participants followed their usual hydration practices during one of the 3 Phases of the study prior to crossing over into the experimental (intervention) group. Participants acted as their own control.
Control group
Active

Outcomes
Primary outcome [1] 336204 0
Body Mass measured by digital scales
Timepoint [1] 336204 0
Immediately before the EXP group instructed to consume preparation drink (days 1, 3, 8 and 10), before physical activity, after physical activity on days 2, 4, 9 and 11 (military training activity days)
Primary outcome [2] 336205 0
Urine specific gravity
Timepoint [2] 336205 0
Beginning and end of days 2, 4, 9 and 11 (military training activity days)
Primary outcome [3] 336206 0
Subjective Health Questionnaire
Timepoint [3] 336206 0
beginning of days 1, 3, 8 and 10 and end of days 2, 4, 9 and 11 of study period
Secondary outcome [1] 427336 0
Physical activity via wrist worn accelerometers
Timepoint [1] 427336 0
Days 2 and 4 and days 9 and 11 of study period

Eligibility
Key inclusion criteria
Australian Army uniformed personnel participating in jungle warfare training
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of medically diagnosed gastrointestinal condition

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants were randomly allocated to either Group A (n=23) or Group B (n=29), via a simple computer-generated sequence.
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
A power analysis was performed based on paired t-tests and the primary outcome of change in body mass. Based on a change in body mass of 1 kg, a standard deviation for the change in body mass of 2.0, and a 2-sided Type 1 error rate of alpha=0.05, a sample size of n=34 was required for 80% power.
Descriptive statistics were used to describe the demographics of study participants and previous location before the study. Only subjects with complete data for all measurement time points were included in the analysis. Data from periods 1 and 2 were pooled. Within-treatment changes from measure 1 to measure 2 were assessed using a paired t-test. The effect of the treatment was assessed by comparing the change between measure 1 and 2 for EXP versus CON. The treatment effects for each period were also assessed using the data from each period only. To test for a possible treatment X period interaction, we compared the treatment effects between periods using an independent t-test of the difference between treatments in period 1 versus the difference between treatments in period 2, with the standard error for this test calculated using the pooled standard error from the 2 periods. To test for possible carryover effects, we compared the weights at measure 1 in period 1 versus weights at measure 1 in period 2 for each group separately using paired t-tests.

An exact test of asymmetry was used to analyze the change in hydration status (based on USG) from pre to post activity for each treatment and for each period. Differences between treatments in self-reported measures of thirst, bloated-ness, refreshed, stomach upset, tiredness and bowel movement were assessed using a Wilcoxon-signed rank test. Significance for all tests was set at a 2-sided Type-1 error rate of alpha=0.05. Data were analyzed using Stata (StataCorp, USA, version 17) and SPSS (IBM Australia, version 27).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2019
Date of last participant enrolment
Anticipated
Actual
20/10/2019
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
34
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314621 0
Government body
Name [1] 314621 0
Defence Science and Technology Group
Country [1] 314621 0
Australia
Primary sponsor type
Government body
Name
Defence Science and Technolgoy Group
Address
76 George St Scottsdale, TAS , 7260
Country
Australia
Secondary sponsor category [1] 316583 0
None
Name [1] 316583 0
Address [1] 316583 0
Country [1] 316583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313644 0
Department of Defence and Veterans Affairs Human Research Ethics Committee
Ethics committee address [1] 313644 0
Ethics committee country [1] 313644 0
Australia
Date submitted for ethics approval [1] 313644 0
24/07/2018
Approval date [1] 313644 0
13/08/2019
Ethics approval number [1] 313644 0
098-19

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

Contacts
Principal investigator
Name 128854 0
Ms Bianka Probert
Address 128854 0
Defence Science and Technology Group, 74 George St Scottsdale, TAS 7260
Country 128854 0
Australia
Phone 128854 0
+61363525142
Fax 128854 0
Email 128854 0
[email protected]
Contact person for public queries
Name 128855 0
Bianka Probert
Address 128855 0
Defence Science and Technology Group, 74 George St Scottsdale, TAS 7260
Country 128855 0
Australia
Phone 128855 0
+61363525142
Fax 128855 0
Email 128855 0
[email protected]
Contact person for scientific queries
Name 128856 0
Bianka Probert
Address 128856 0
Defence Science and Technology Group, 74 George St Scottsdale, TAS 7260
Country 128856 0
Australia
Phone 128856 0
+61363525142
Fax 128856 0
Email 128856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, after de-identification.
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication.
Available to whom?
Only available on a case-by-case basis to reserachers who meet the criteria for access to confidential data at the discretion of the Defence and Veterans Affairs Human Research Ethics Committee.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data are available from the authors upon resonable request and release approval from the Ethics Committee (contact via [email protected]) for researchers who meet the criteria for access to confidential data.


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.