Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000289415
Ethics application status
Approved
Date submitted
27/10/2024
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of alternative carbohydrate blends on performance
Scientific title
Effect of alternative carbohydrate blends on endurance performance in male cyclists
Secondary ID [1] 313257 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHOBlends
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise fatigue 335575 0
Condition category
Condition code
Metabolic and Endocrine 332145 332145 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions are various blends of carbohydrates with details not disclosed.

Protocols and procedures:

Initial meeting, study explanation and screening for inclusion/exclusion criteria will be provided by a telephone, in person, or online consultation. Participants will be able to ask any questions and have the questions answered. If parties are happy, participants will be invited to sign the consent form. Following which, participants will be asked to complete the health screening questionnaire. If no precluding health issues are revealed, then a date and time for the Visit 1 will be arranged.
Visit 1, being VO2max/Wmax test and familiarization trial of the performance test. Participants will modify and record their cycle training and repeat on a weekly basis according to the weekly block: day 1, 3–4 h training ride; days 2, medium-duration ride (2–3 h); day 3, rest or easy intensity training day; day 4, standardized ride in the laboratory (2.5 h simulated cycle race protocol with breath sampling); day 5, rest day or short ride; day 6, experimental trial; and day 7, recovery ride. Day 4 and 6 trials will be conducted at the same time of morning after an overnight fast, 500 mL water, and standardized provided meals and fluid from breakfast the day prior (snacks, dinner provided).
To reduce background 13C enrichment, participants will be provided with extensive food lists and instructed not to eat foods with components derived from plants naturally enriched with 13C (i.e., maize, sugar cane) for at least 10 d before the first experimental trial and for the duration of the study.
To standardize diet, participants will be provided food based on energy expenditure on protocols days 3-5. These diet patterns will be repeated before each of the subsequent trials.
Protocols. Exercise tests will be conducted using the electronically braked cycle ergometers (VeloTron) and expired gas analysis using calibrated systems (Parvomedics and Cosmed). The VO2max/Wmax test will be the standard 2.5 min ramp [1, 3]. Height, weight, and fat and lean mass will be measured using stadiometer and skinfold calipers, On day 4 and 6, 1-2 participants will report to the laboratory between 0600 and 0900 h as arranged.
All participants will conduct the same experimental procedures. However, only n=8 will have expired gas collected during exercise. We have calculated that n=8 is sufficient power for the anticipated effect size for this secondary mechanistic outcome and in addition to save costs on limited study budget. The remaining 4 participants will perform the same exercise but without the expired respiratory gas collection. The following two paragraphs describe the metabolic procedures.
The test ride on day 4 is to assay 13C background under and to standardize metabolic and training conditions induced by the test carbohydrate used prior to performance testing on day 6, but with carbohydrate comprising background enrichment; it will comprise a 2.25-h ride of the same protocol as the day 6 ride to 135 min. The study drink will comprise the same make-up and concentration as the test drinks, but with carbohydrate containing background 13C enrichment and containing salt and flavorings ingested at the same time points and rate as the test drinks.
The metabolic and performance test on day 6 will comprise a modified version of the simulated cycle race protocol used previously [4] consisting of a 2.5-h of stochastic-intensity riding between 30 and 95% Wmax, followed with a double-blind performance test comprising a constant-power time to exhaustion text at 67.5% of Wmax (~74%VO2max). During the stochastic preload, breath samples will be collected during the final 3 min of two 10 min periods at 67.5% Wmax to measure exogenous-carbohydrate, endogenous-carbohydrate (glycogen), and fat oxidation rate during exercise, Expired breath will be collected as triplicate samples into exetainers (Exetainer, Labco Ltd., High Wycombe, UK) and external respiration for VO2 and VCO2 (Moxus, COSMED, Parvomedics). Breath samples will be analyzed in the UK using gas-isotope ratio mass spectroscopy (Sercon, Crewe, UK).
On day 6, after arrival at the lab and toileting, participants will have their body mass recorded then will be seated on the Velotron cycle ergometer to complete resting baseline gut comfort and psychometric scales. They will then mount the bike and ingest the first single bolus of test drink and begin the test ride. Gut comfort and psychometric scales will be collected at min 14 of each 15 min sampling block, followed by experimental drink ingestion.
During all rides, environmental conditions will be maintained at 21-22oC by air conditioning and ambient relative humidity (50-60%); conditions will be recorded at the beginning, middle and end of the test and parameters will be included as modifying covariates in the statistical analysis. Standardized airflow will be maintained over the subjects by a powerful fan set at a standard rate and position relative to the shoulders and face of the rider and unchanged over the course of the ride or experiment.
Carbohydrate drinks. Following the initial 200-mL drink, further 200 mL drinks will be ingested at 15-min intervals. All drinks be delivered double-blind.
The total carbohydrate in the drinks and ingestion rate was derived from the mean rate ingested of 1.5 g·min-1 (90 g·h-1) [1, 6]. All drinks will have lime juice (16 g·L-1), citric acid (1.0 g·L-1) and 20 mmol·L-1 (1.17 g·L-1) NaCl.
Psychometric scales. The effect of drink on physical exertion, gastrointestinal comfort, and drink sweetness will be recorded at rest, every 30 min during the pre-load ride prior to drink ingestion, but not during the performance test to minimize distraction and to remove time-duration cues for the athlete.

1. O'Brien WJ, Stannard SR, Clarke JA, Rowlands DS. Fructose-maltodextrin ratio governs exogenous and other cho oxidation and performance. Medicine and Science in Sports and Exercise. 2013;45:1814-24.
2. Hopkins WG, Schabort EJ, Hawley JA. Reliability of power in physical performance tests. Sports Med. 2001;31:211-34.
3. O'Brien WJ, Rowlands DS. Fructose-maltodextrin ratio in a carbohydrate-electrolyte solution differentially affects exogenous carbohydrate oxidation rate, gut comfort, and performance. Am J Physiol Gastroint Liver Physiol. 2011;300:G181-G9.
4. Guillochon M, DS R. Solid, Gel, and Liquid Carbohydrate Format Effects on Gut Comfort and Performance. International Journal of Sport Nutrition and Exercise Metabolism. 2017;27:147-54.
5. Odell OJ, Podlogar T, Wallis GA. Comparable Exogenous Carbohydrate Oxidation from Lactose or Sucrose during Exercise. Med Sci Sports Exerc. 2020;52:2663-72.
6. Ijaz A, Collins A, Moreno-Cabañas A, Bradshaw L, Betts J, Podlogar T, et al. Exogenous glucose oxidation during exercise is positively related to body size. Research Square. 2024;PrePrint.
7. Verbraecken J, Van de Heyning P, De Backer W, Van Gaal L. Body surface area in normal-weight, overweight, and obese adults. A comparison study. Metabolism - Clinical and Experimental. 2006;55:515-24.
8. Du Bois D, Du Bois EF. Clinical calorimetry: tenth paper a formula to estimate the approximate surface area if height and weight be known. Archives of Internal Medicine. 1916;XVII:863-71.
Intervention code [1] 329835 0
Treatment: Other
Comparator / control treatment
Glucose at 90 g/h ingestion rate (ratio withheld; dose see Description of intervention(s) / exposure)
Control group
Active

Outcomes
Primary outcome [1] 339733 0
time to exhaustion
Timepoint [1] 339733 0
Day 6 of the weekly intervention study block within the 4-arm crossover design
Secondary outcome [1] 441026 0
ratings of fatigue
Timepoint [1] 441026 0
Day 6 of the weekly intervention study block within the 4-arm crossover design during the exercise procedures
Secondary outcome [2] 441027 0
measures of gut comfort
Timepoint [2] 441027 0
Day 6 of the weekly intervention study block within the 4-arm crossover design during the exercise procedures
Secondary outcome [3] 441267 0
Exogenous and endogenous carbohydrate and fat oxidation rate during exercise.
Timepoint [3] 441267 0
Day 6 of the weekly intervention study block within the 4-arm crossover design during the exercise procedures

Eligibility
Key inclusion criteria
aged 18-60 y;
VO2max >55 ml·kg fat free mass·min-1
training >8/h in recent prior months.
competition experience
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to leg bicycle.
Recent heart surgery or any other contraindication to intense exercise as advised by GP
diabetes
current or recent cold or flu
Vertigo, back pain exaggerated with prolonged cycling
Contra-indicated gastrointestinal, liver, kidney diseases
Recent lower limb injury
Joint problems that may be aggravated with the study exercise

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square 4-way matrix (4 sequences of treatment allocation order) applied by order of participant recruitment in blocks of 4 participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants. Sample size of 12 endurance trained male (aged 18-60 y; VO2max >55 ml·kg fat free mass·min-1) was estimated from a similar study with a smallest change of 2.1% differences in power during repeated-sprint high-intensity endurance performance tasks influenced by changes in carbohydrate blend (O'Brien et al, 2013) using null hypothesis significance testing, alpha=5%, beta=80%, SE (CV%) 1.65%, SD 18%. Using the same effect magnitudes and error statistics by in the conservative superiority testing, with 0.5% type-1 and 5% type-II error rates, provides a 75% likelihood the 95%CI sits above 1.95% (95%CI 0.6, 3.3%) and 0.5% likelihood it sits below -1.95%, providing a benefit/harm ratio on performance >100,000:1.
While it is important to understand the reliability of the proposed performance test, the test also has to be practical and optimal for the possible mechanism. The repeated-sprint test is likely limited by glycogen – which includes anaerobic power output, but until running low, is also limited by VO2max. It does require careful operation by the researchers but is achievable. The repeated sprint test is high demanding on the participants but is mental short duration task (~2 min maximal efforts) so less likely to be affected by concentration slips. The alternative test proposed is currently the 2.5-h preload followed by either a constant-power time to exhaustion text at 65% of Wmax (~72%VO2max), which complies with the intensity used in classical glycogen-limiting sports drink and carbohydrate loading studies and has the lower CV% for equivalent mean power in well-trained cyclists of around 0.7 to 1.4% (Hopkins et al, 2001), which is amongst the highest reliability tests available and specific to a glycogen-availability mechanism that accommodates variability in endurance capacity between the cohort of qualifying. The test will complete blind to any performance feedback.

Statistical analysis. Treatment effects on outcomes will be estimated with mixed models in SAS. All data except psychometric will be log-transformed prior to analysis. Fixed effects will be treatment, period and sequence accounting for familiarization, adaptation, or fatigue effects between consecutive trials and the order of exposure. Outcomes will be adjusted for any variation in lab environmental conditions. For repeated-measures data, the x-axis variable will be centered for linear modeling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/03/2025
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
12
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 26657 0
New Zealand
State/province [1] 26657 0

Funding & Sponsors
Funding source category [1] 317703 0
University
Name [1] 317703 0
Massey University
Country [1] 317703 0
New Zealand
Funding source category [2] 317704 0
Commercial sector/Industry
Name [2] 317704 0
Arla Food Ingredients
Country [2] 317704 0
Denmark
Funding source category [3] 317705 0
Government body
Name [3] 317705 0
Kiwinet
Country [3] 317705 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 320025 0
Commercial sector/Industry
Name [1] 320025 0
Arla Food Ingredients
Address [1] 320025 0
Country [1] 320025 0
Denmark
Secondary sponsor category [2] 320026 0
Commercial sector/Industry
Name [2] 320026 0
Kiwinet
Address [2] 320026 0
Country [2] 320026 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316400 0
Massey University Human Ethics Committee: Ohu Matatika 1 (formerly Southern A Committee)
Ethics committee address [1] 316400 0
Ethics committee country [1] 316400 0
New Zealand
Date submitted for ethics approval [1] 316400 0
24/01/2025
Approval date [1] 316400 0
19/03/2025
Ethics approval number [1] 316400 0
OM1 25/02

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

Contacts
Principal investigator
Name 137770 0
Prof David Rowlands
Address 137770 0
School of Sport and Exercise and Nutrition. Massey Univerisity Auckland. 151 Dairy Flat Highway, Albany, Auckland 0632, New Zealand
Country 137770 0
New Zealand
Phone 137770 0
+64 9 2136616
Fax 137770 0
Email 137770 0
[email protected]
Contact person for public queries
Name 137771 0
David Rowlands
Address 137771 0
School of Sport and Exercise and Nutrition. Massey Univerisity Auckland. 151 Dairy Flat Highway, Albany, Auckland 0632, New Zealand
Country 137771 0
New Zealand
Phone 137771 0
+64 9 2136616
Fax 137771 0
Email 137771 0
[email protected]
Contact person for scientific queries
Name 137772 0
David Rowlands
Address 137772 0
School of Sport and Exercise and Nutrition. Massey Univerisity Auckland. 151 Dairy Flat Highway, Albany, Auckland 0632, New Zealand
Country 137772 0
New Zealand
Phone 137772 0
+64 9 2136616
Fax 137772 0
Email 137772 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Once the data is determined suitable for release into the public domain, anyone may request access to it, or it may be deposited to a journal website if the particular journal that chooses to accept the study has such a facility; if not, the data will be made available to the public by way of contact to the PI.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Outcome data in non-identified format

What types of analyses could be done with individual participant data?
• To achieve the aims intended. For meta-analysis. To add to datasets to extend inference in the area intended.

When can requests for individual participant data be made (start and end dates)?
From:
after any possible new IP is protected or commercialisation or further science advancement drawn to conclusion. timeline is unknown at this time.

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• By emailing the principal investigator ([email protected]). likely the journal supplementary data repository or from the researchers if suitable with respect to journal criteria.

Are there extra considerations when requesting access to individual participant data?
No


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.