Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000091606
Ethics application status
Approved
Date submitted
12/01/2023
Date registered
25/01/2023
Date last updated
9/10/2023
Date data sharing statement initially provided
25/01/2023
Date results information initially provided
9/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Lactose as an Alternative Carbohydrate in Sports Food Within Male Athletes.
Scientific title
Lactose as an Alternative Carbohydrate to High-Fructose Carbohydrate in Exercise Nutrition: Can Enhanced Fat Metabolism and Glycogen-Sparing Effects of Lactose Improve Endurance Performance in Male Athletes?
Secondary ID [1] 308685 0
PR96444 AMURP
Universal Trial Number (UTN)
Trial acronym
LACSUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sporting Performance 328613 0
Condition category
Condition code
Diet and Nutrition 325622 325622 0 0
Other diet and nutrition disorders
Musculoskeletal 325782 325782 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will include 7 visits to the laboratory per participant including:

1. Familiarisation trial of the performance test, and measurements of VO2 max and Wmax.
The familiarisation trial is anticipated to take approximately 2.5 hours. The VO2 max test will be conducted only on stationary bikes through gas sampling and converted to VO2 through the Moxus software.

2. On a weekly basis (or longer to 4 weeks depending on participant availability schedule) - three steady state rides for 2 hours at 57.5% Wmax to establish background metabolism of 13C. These background visits will also take approximately 2.5 hours.

3. On a weekly basis and two days after each of the background tests - three experimental trials consisting of a 2 hour ride at 57.5% Wmax and a performance test including 10 x 2 minute maximal sprint efforts. These experimental trial visits will take approximately 3 hours to complete, and the washout period between each experimental trial is at least 7 days for each participant.

During the experimental trials, carbohydrate drinks will be provided at 15 minute intervals. The drinks will consist of either a lactose-fructose blend, a fructose-maltodextrin blend, or maltodextrin only. The lactose-fructose blend will be ingested at 1.5 g/min with lactose at 0.8g/min and fructose at 0.7 g/min. The maltodextrin-fructose blend will also be ingested at 1.5g/min with maltodextrin at 0.8g/min and fructose at 0.7g/min. The maltodextrin will be ingested at 1.5 g/min. The drinks will be 200 ml per serve and also all contain lime juice (16 g/L), citric acid (1.0 g/L) and NaCl (20mmol/L).

To monitor adherence, each cyclist will have an individual researcher responsible for supplying the drinks and ensuring that the full dose is completed and on time.
Intervention code [1] 325163 0
Treatment: Other
Comparator / control treatment
No placebo will be used. Instead, two active controls of (a) maltodextrin (0.8g/min) and fructose (0.7g/min) (current industry best practice) and (b) maltodextrin only (1.5 g/min) will be used as a comparison. All drinks will be placebo constructed with identical flavour and similar sweetness profile. The study will be conducted double blind.
Control group
Active

Outcomes
Primary outcome [1] 333486 0
Mean power in the performance test. The performance test will include ten maximal sprints consisting of roughly 2 minutes each. This will not assess a specific muscle group, but overall physical fitness instead.
Timepoint [1] 333486 0
End of exercise procedure for each study arm, approx. 2 hours after steady state cycling.
Secondary outcome [1] 417242 0
.Exogenous carbohydrate oxidation during exercise. Carbohydrate oxidation will be calculated using the breath analysis through calculations described in the study below.

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.
Timepoint [1] 417242 0
.During the second hour of the 2-h ride at 57.5%Wmax. Collected every 30 mins starting from minute 58.
Secondary outcome [2] 417480 0
Endogenous carbohydrate oxidation during exercise. Carbohydrate oxidation will be calculated using the breath analysis through calculations described in the study below.

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.
Timepoint [2] 417480 0
During the second hour of the 2-h ride at 57.5%Wmax. Collected every 30 mins starting from minute 58.
Secondary outcome [3] 417481 0
Endogenous fat oxidation rate. Fat oxidation will be calculated using the breath analysis through calculations described in the study below.

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.
Timepoint [3] 417481 0
During the second hour of the 2-h ride at 57.5%Wmax. Collected every 30 mins starting from minute 58.
Secondary outcome [4] 417482 0
Gut comfort.

Psychometric scales, that are designed specifically for this study, will be used to asses gut comfort.
Timepoint [4] 417482 0
Through out the exercise protocol sampled at 15 min intervals, for a total of 3.5 hours.

Eligibility
Key inclusion criteria
Endurance trained, lactose tolerant males with a VO2 max > 50 ml.kg/min
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females

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 will be concealed via numbered container and central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomization table from Williams design Latin Square for 3 treatments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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
28/04/2023
Actual
28/04/2023
Date of last participant enrolment
Anticipated
1/08/2023
Actual
20/07/2023
Date of last data collection
Anticipated
1/09/2023
Actual
20/09/2023
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 25202 0
New Zealand
State/province [1] 25202 0

Funding & Sponsors
Funding source category [1] 312916 0
University
Name [1] 312916 0
Massey University Research Fund
Country [1] 312916 0
New Zealand
Primary sponsor type
Individual
Name
David Rowlands
Address
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 314593 0
University
Name [1] 314593 0
Massey University
Address [1] 314593 0
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country [1] 314593 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312189 0
Northern Committee - Health and Disability Ethics Committee
Ethics committee address [1] 312189 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 312189 0
New Zealand
Date submitted for ethics approval [1] 312189 0
04/02/2022
Approval date [1] 312189 0
14/12/2022
Ethics approval number [1] 312189 0
HDEC11632

Summary
Brief summary
The aim of the study is to confirm that lactose (ordinary milk sugar) ingestion substantially increases fat oxidation and spares glycogen utilization, relative to a high-fructose carbohydrate (sucrose). We are also interested in exploring the possibility that the lactose-mediated effect on fat oxidation is maintained or even enhanced when blended with another carbohydrate, fructose, which has been previously shown to spare glycogen through this mechanism. Secondly, we aim to provide data to answer the question of whether lactose or a lactose-fructose blend may enhance performance in tests of endurance that are likely limited by muscle glycogen availability and optimized through increasing endogenous fat oxidation. Such tests are those that likely replicate the physiological work intensities experienced during strenuous high-intensity sport competition. Finally, the current research will establish in lactose tolerant individuals if there are any adverse gastrointestinal effects of lactose ingestion during high-intensity exercise.
Trial website
https://tinyurl.com/mujmy58f
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123786 0
Prof David Rowlands
Address 123786 0
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country 123786 0
New Zealand
Phone 123786 0
+64 92136616
Fax 123786 0
Email 123786 0
d.s.rowlands@massey.ac.nz
Contact person for public queries
Name 123787 0
Miss Alex Murphy
Address 123787 0
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country 123787 0
New Zealand
Phone 123787 0
+64 223900714
Fax 123787 0
Email 123787 0
a.murphy@massey.ac.nz
Contact person for scientific queries
Name 123788 0
Prof David Rowlands
Address 123788 0
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country 123788 0
New Zealand
Phone 123788 0
+64 92136616
Fax 123788 0
Email 123788 0
d.s.rowlands@massey.ac.nz

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.