Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000758909
Ethics application status
Approved
Date submitted
5/06/2020
Date registered
23/07/2020
Date last updated
25/11/2021
Date data sharing statement initially provided
23/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of sports-hydration drinks on hydration and exercise performance while cycling in the heat
Scientific title
Effects of a high amylose resistant starch sports-hydration drink on plasma volume and performance while cycling in the heat
Secondary ID [1] 301117 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dehydration 317211 0
Exercise performance
 317212 0
Condition category
Condition code
Cardiovascular 315351 315351 0 0
Normal development and function of the cardiovascular system
Oral and Gastrointestinal 315352 315352 0 0
Normal oral and gastrointestinal development and function
Musculoskeletal 315353 315353 0 0
Normal musculoskeletal and cartilage development and function
Diet and Nutrition 315756 315756 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will consume a high amylose maize starch (HAMS) sports-hydration solution (350mL, containing 33g of resistant starch) six hours prior to completing an exercise trial. The exercise trial will include two sub-maximal cycling bouts of one hour at a power output equal to 50% of maximal oxygen uptake, followed by a maximal 10-minute time trial. Participants will then be allowed to rest for 90 minutes. A second HAMS sports-hydration solution (350mL, containing 16.27g of resistant starch) will be consumed at the start of the rest period. All testing will be completed within an environmental chamber set at 30 degrees Celsius with a relative humidity of 50%. Participants will undergo a wash out period of at least 7 days before returning for the control trial. Participants will record consumption of all food and drinks on the day of the trial and will return empty containers.
Intervention code [1] 317428 0
Treatment: Other
Comparator / control treatment
All participants will consume a placebo solution six hours prior to completing an exercise trail. The carbohydrate concentration in the control solution will match that of the HAMS sports-hydration solution. The exercise trial will include two sub-maximal cycling bouts of one hour at a power output equal to 50% of maximal oxygen uptake, followed by a maximal 10-minute time trial. Participants will then be allowed to rest for 90 minutes. They will be provided with water during the rest period. All testing will be completed within an environmental chamber set at 30 degrees Celsius with a relative humidity of 50%.
Control group
Placebo

Outcomes
Primary outcome [1] 323607 0
Exercise performance as assessed by energy expenditure accumulated over 10-minutes. Calculated by Lode bike excalibur bike.
Timepoint [1] 323607 0
Collected at the completion of the 10-minute time trial.
Primary outcome [2] 323610 0
Plasma volume change using the Dill and Costill (1974) method.
Timepoint [2] 323610 0
Baseline, before and after 10-minute time trial and end of 90-minute recovery.
Primary outcome [3] 323611 0
Urine specific gravity using refractometer.
Timepoint [3] 323611 0
Collected at all time points (Baseline, between cycling bouts, before and after 10-minute time trial and end of 90-minute recovery).
Secondary outcome [1] 382335 0
Body mass
Timepoint [1] 382335 0
Collected at all time points (Baseline, between cycling bouts, before and after 10-minute time trial and end of 90-minute recovery).
Secondary outcome [2] 382336 0
Blood Lactate using EFK Lactate Scout 4 Lactate analyser.
Timepoint [2] 382336 0
Collected at baseline, before and after 10-minute time trial and end of 90-minute recovery.
Secondary outcome [3] 382337 0
Urine Colour
Timepoint [3] 382337 0
Collected at all time points (Baseline, between cycling bout, before and after 10-minute time trial and end of 90-minute recovery).
Secondary outcome [4] 382338 0
Digestive comfort - visual analogue scale
Timepoint [4] 382338 0
Collected at all time points (Baseline, between cycling bouts, before and after 10-minute time trial and end of 90-minute recovery).
Secondary outcome [5] 382339 0
Heart rate using a chest strap heart rate monitor and Polar GPS running watch
Timepoint [5] 382339 0
Collected during both one-hour cycling bouts, 10-minute time trial and during recovery.
Secondary outcome [6] 382344 0
Rating of perceived exertion - BORG 6-20 Scale.
Timepoint [6] 382344 0
Collected during both one-hour cycling bout, 10-minute time trial and during recovery.
Secondary outcome [7] 382346 0
Thirst - visual analogue scale.
Timepoint [7] 382346 0
Collected during both one-hour cycling bouts, 10-minute time trial and during recovery.

Eligibility
Key inclusion criteria
- Male and female aged between 18 and 55 years.
- Non-smoker (minimum 6 months).
- Must complete at least 150 minute of vigorous cycling per week.
- Must meet or exceed a relative maximal oxygen uptake of 55ml/kg/min for males and 45ml/kg/min for females.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Answered yes to any question in stage 1 of the Exercise and Sport Science Australia, Fitness Australia, Sports Medicine Australia and Exercise is Medicine's "Adult Pre-Exercise Screening System".
- Resting blood pressure above 140/90 mmhg.
- Have a cardiovascular or metabolic condition that imposes a health risk during exercise.
- Regular use any medication or supplements that may alter heart rate or exercise performance.
- Are unwilling to provide urine or have blood samples taken.
- Are unwilling to unable to provide written consent.
- Have gastrointestinal issues.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using a randomisation table created by Microsoft excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on changes in Plasma Volume (PV) based on an effect size of 0.4, power of 0.8 with a 0.05 significance level, we would require a minimum of 12 participants.
15 participants will be recruited to allow for withdrawals.
Data will be analysed using IBM’s SPSS Statistics 25. Between group differences will be determined using a repeated measures ANOVA, This method of analysis will allow us to compare the mean measurement scores of both the intervention and control trials at each of the five measurement collection points [Measurement for Haematocrit, Haemoglobin, Urine specific gravity, Body mass, Blood lactate and Urine colour] and separately across the three cycling stages [Measurement for power output, Heart rate, Time, Rating of perceived exertion (BORG 6-20 Scale) and Thirst]. Statistical significance will be set at P<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2020
Actual
3/08/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
15/06/2021
Date of last data collection
Anticipated
31/12/2020
Actual
29/06/2021
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 30118 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305561 0
University
Name [1] 305561 0
University of South Australia
Country [1] 305561 0
Australia
Funding source category [2] 306023 0
Commercial sector/Industry
Name [2] 306023 0
Preserve Health PTY LTD
Country [2] 306023 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide, South Australia, 5000.
Country
Australia
Secondary sponsor category [1] 305968 0
Individual
Name [1] 305968 0
Doctor Alison Hill
Address [1] 305968 0
University of South Australia, UniSA Clinical and Health Sciences; Alliance for Research in Exercise, Nutrition and Activity.
108 North Terrace, Adelaide, South Australia, 5000.
Country [1] 305968 0
Australia
Secondary sponsor category [2] 305982 0
Individual
Name [2] 305982 0
Professor Alison Coates
Address [2] 305982 0
University of South Australia, UniSA Allied Health and Human Performance; Alliance for research in Exercise, Nutrition and Activity.
108 North Terrace, Adelaide, South Australia, 5000.
Country [2] 305982 0
Australia
Secondary sponsor category [3] 305983 0
Individual
Name [3] 305983 0
Doctor Samuel Chalmers
Address [3] 305983 0
University of South Australia, UniSA Allied Health and Human Performance; Alliance for Research in Exercise Nutrition and Activity.
108 North Terrace, Adelaide, South Australia, 5000.
Country [3] 305983 0
Australia
Secondary sponsor category [4] 305984 0
Individual
Name [4] 305984 0
Doctor Chris Della Vedova
Address [4] 305984 0
University of South Australia, UniSA Clinical and Health Sciences.
108 North Terrace, Adelaide, South Australia, 5000.
Country [4] 305984 0
Australia
Secondary sponsor category [5] 306293 0
Individual
Name [5] 306293 0
Carter Lisk
Address [5] 306293 0
University of South Australia, UniSA Allied Health and Human Performance; Alliance for Research in Exercise Nutrition and Activity.
108 North Terrace, Adelaide, South Australia, 5000.
Country [5] 306293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305867 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 305867 0
Ethics committee country [1] 305867 0
Australia
Date submitted for ethics approval [1] 305867 0
30/07/2019
Approval date [1] 305867 0
28/05/2020
Ethics approval number [1] 305867 0
202485

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

Contacts
Principal investigator
Name 101866 0
Dr Alison Hill
Address 101866 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, South Australia, 5001, Australia.
Country 101866 0
Australia
Phone 101866 0
+61 8 830 21817
Fax 101866 0
Email 101866 0
[email protected]
Contact person for public queries
Name 101867 0
Alison Hill
Address 101867 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, South Australia, 5001, Australia.
Country 101867 0
Australia
Phone 101867 0
+61 8 830 21817
Fax 101867 0
Email 101867 0
[email protected]
Contact person for scientific queries
Name 101868 0
Alison Hill
Address 101868 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, South Australia, 5001, Australia.
Country 101868 0
Australia
Phone 101868 0
+61 8 830 21817
Fax 101868 0
Email 101868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made public as the study is not publicly funded.


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.