Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000992707
Ethics application status
Approved
Date submitted
6/07/2022
Date registered
14/07/2022
Date last updated
25/06/2024
Date data sharing statement initially provided
14/07/2022
Date results provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
McArdle disease and carbohydrate ingestion before exercise: The effect of timing
Scientific title
McArdle disease and carbohydrate ingestion before exercise: The effect of timing
Secondary ID [1] 307481 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
McArdle Disease 326876 0
Condition category
Condition code
Musculoskeletal 324086 324086 0 0
Other muscular and skeletal disorders
Diet and Nutrition 324087 324087 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 324088 324088 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research involves bringing greater clarity to the highly contentious McArdle disease (MD) clinical practice guidelines of consuming sucrose before exercise,

The trials aim to determine conditions under which the ingestion of sucrose prior to exercise would be of most benefit to an individual with MD
Prior to experimental testing each participant will undertake exercise testing to determine maximal continuous exercise capacity. Conventional methods (VO2max testing) are not appropriate for measurement of aerobic exercise capacity in individuals with MD due to substrate availability being the limiting factor during exercise and not O2 consumption. As a result, a maximum steady state power output (PPO) will be used to determine exercising capacities. .
The repeated measures experimental trials will consist of 3 separate sessions (one experimental trial per session) each separated by a minimum of 48 hours. For each trial, participants will arrive at the laboratory at ~7.30 am in fasted state. Upon arrival, a cannula will be placed into the antecubital vein and a resting blood sample (6 mL) will be drawn. In a randomised, crossover design participants will be allocated one of 3 experimental protocols for each session:
1) Sucrose 25 mins before exercise (SUC25)
2) Sucrose 5 mins before exercise (SUC5)
3) A placebo group (PLA)
Once the participant has been assigned to an experimental protocol, they will be fitted with a heart rate monitor and will consume the designated beverage of the condition (sucrose or placebo). Sucrose protocols will consume a beverage containing 37 g of sucrose with 250 mL of water. Fasted protocols will consume 250 mL of water artificially sweetened zero-carbohydrate substitute to blind participants for conditions. 5-minutes after the consumption of the designated beverage, participants undertaking the SUC5 trial will then be fitted with a mouthpiece to collect continuous expired breath, a second blood sample will be taken, and participants will begin cycling at a steady state at 60% of their previously determined PPO.
25-minutes after the consumption of the designated beverage, participants undertaking the SUC25 trial will then be fitted with a mouthpiece to collect continuous expired breath, a second blood sample will be taken, and participants will begin cycling at a steady state at 60% of their previously determined PPO.
Blood samples will be taken at 0,5, 10, 15, and 20 minutes of each exercise trial. Expired gas, and heart rate will be continually collected throughout the 20 minute trials. Rating of perceived exertion (RPE) will be collect at every 1 minute interval using a 20 point Borg scale.

The trials will take place under the guidance and supervisor of highly qualified and experienced Exercise Scientists and Exercise Physiologists.

Intervention code [1] 323933 0
Treatment: Other
Comparator / control treatment
250 mL of water artificially sweetened with a zero-carbohydrate substitute (placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 331883 0
Peak heart rate achieved during each condition.
Timepoint [1] 331883 0
Heart rate will be measured continuously during each 20 minute cycling trial using a Polar heart rate monitor.
Primary outcome [2] 331975 0
Peak RPE during each condition of the 20-minute exercise trials. RPE will be measure at one minute intervals during 20 minute cycling trials using a 20 point Borg scale
Timepoint [2] 331975 0
RPE will be measure at one minute intervals during 20 minute cycling trials using a 20 point Borg scale
Primary outcome [3] 338634 0
Average Heart Rate. Heart rate will be continuously measured during cycling sessions using a Polar heart rate monitor.
Timepoint [3] 338634 0
Primary outcome [4] 338635 0
Average Heart Rate. Heart rate will be continuously measured during cycling sessions using a Polar heart rate monitor.
Timepoint [4] 338635 0
Heart rate will be recorded continuously over the course of each 20 minute trial
Secondary outcome [1] 411492 0
Skeletal muscle damage will be assessed during experimental cycling sessions via blood draws for myoglobin,
Timepoint [1] 411492 0
Blood draws for myoglobin analysis will take place 10 hours post second 20 minute experimental cycling sessions
Secondary outcome [2] 436750 0
Average heart rate during each condition of the 20-minute exercise trials



Timepoint [2] 436750 0
Secondary outcome [3] 436751 0
Average heart rate during each condition of the 20-minute exercise trials



Timepoint [3] 436751 0
Heart rate will be recorded continuously over the course of each 20-minute trial Using a Polar heart rate monitor

Eligibility
Key inclusion criteria
• Previously medically confirmed MD (biopsy/genetically confirmed)
• Ambulatory and able to perform the cycling tests independently (i.e. not in a wheelchair)
• Must have the capacity to exercise intermittently for ~1 hour
• Not currently involved in or plan start any exercise regimen designed to increase aerobic capacity and be willing to remain on their current exercise regimen for the duration of the study.
• Must not have donated blood within the last 30 days and must not donate blood for the duration of the study.
• Concomitant medications (including supplements and birth control) must be stable for at least 1 month prior to enrolment and throughout participation in the study.
• Medical clearance from a General Practitioner to confirm they have medical clearance to complete the physical activity outlined in the testing protocol.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pre-existing conditions that would be aggravated by stationary cycling, such as cardiovascular diseases or musculoskeletal injury or weakness
• Type I or Type II diabetes
• Pregnant or nursing females.
• Current or prior use of anabolic steroids or other prohibited substances

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)
Sealed opaque envelopes will be used to blind both the participant and the research of trial order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin Square
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/10/2022
Actual
6/06/2023
Date of last participant enrolment
Anticipated
1/07/2023
Actual
9/02/2024
Date of last data collection
Anticipated
30/07/2023
Actual
15/02/2024
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311759 0
Charities/Societies/Foundations
Name [1] 311759 0
International Association for Muscle Glycogen Storage Disease (IAMGSD)
Country [1] 311759 0
United States of America
Primary sponsor type
Individual
Name
Mr Sam Torrens
Address
A113, O Block, Kelvin Grove Campus
School of Exercise and Nutrition Sciences
Queensland University of Technology
Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 313253 0
Individual
Name [1] 313253 0
Associate Professor Robert Robergs
Address [1] 313253 0
O Block, Kelvin Grove Campus
School of Exercise and Nutrition Sciences
Queensland University of Technology
Kelvin Grove, Queensland, 4059
Country [1] 313253 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311202 0
Queensland University of Technology (QUT) School of School of Exercise & Nutrition Sciences, Faculty of Health Research Ethics Committee
Ethics committee address [1] 311202 0
Ethics committee country [1] 311202 0
Australia
Date submitted for ethics approval [1] 311202 0
06/07/2022
Approval date [1] 311202 0
22/03/2023
Ethics approval number [1] 311202 0

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

Contacts
Principal investigator
Name 120310 0
Mr Sam Torrens
Address 120310 0
A113, O Block, Kelvin Grove Campus
School of Exercise and Nutrition Sciences
Queensland University of Technology
Kelvin Grove, Queensland, 4059
Country 120310 0
Australia
Phone 120310 0
+61 0493072700
Fax 120310 0
Email 120310 0
[email protected]
Contact person for public queries
Name 120311 0
Sam Torrens
Address 120311 0
A113, O Block, Kelvin Grove Campus
School of Exercise and Nutrition Sciences
Queensland University of Technology
Kelvin Grove, Queensland, 4059
Country 120311 0
Australia
Phone 120311 0
+61 0493072700
Fax 120311 0
Email 120311 0
[email protected]
Contact person for scientific queries
Name 120312 0
Sam Torrens
Address 120312 0
A113, O Block, Kelvin Grove Campus
School of Exercise and Nutrition Sciences
Queensland University of Technology
Kelvin Grove, Queensland, 4059
Country 120312 0
Australia
Phone 120312 0
+61 0493072700
Fax 120312 0
Email 120312 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.