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Trial registered on ANZCTR


Registration number
ACTRN12622000517774
Ethics application status
Approved
Date submitted
21/03/2022
Date registered
31/03/2022
Date last updated
20/02/2023
Date data sharing statement initially provided
31/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of French bark extract, Pycnogenol, as a supplement to improve exercise performance in a population of cyclists.
Scientific title
Evaluation of the effects of supplementation with Pycnogenol (French Pinus pinaster bark extract) on exercise performance in a population of cyclists: A double blind crossover trial.
Secondary ID [1] 306574 0
Nil known
Universal Trial Number (UTN)
U1111-1275-4893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exercise performance 325524 0
Condition category
Condition code
Alternative and Complementary Medicine 322893 322893 0 0
Other alternative and complementary medicine
Musculoskeletal 322894 322894 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single blind crossover trial, placebo controlled study will be conducted in which male and female subjects who actively participate in cycling, will supplement their normal daily lives with either Modex (100ml containing 260mg Pycnogenol, 240mg Papin, 300mg Sodium chloride, 175mg Aloe Vera, 169mg Procyanidins, once daily), or placebo (100ml of Modex formula containing everything but Pycnogenol, once daily), oral drink for 4 weeks.

Prior to the 4-week supplement periods, participants will have a VO2 max tested and 30 minute cycling test conducted at La Trobe University strength and conditioning gym (Bundoora campus), supervised by qualified exercise physiologists. After the 4-week supplement period, participants will undergo s 30 minute cycle test once again. These 3 sessions will involve a health screen, and the taking of blood samples. This will require a session time for each participant of 60 min, a total of 3 hours.

To monitor adherence, we will be monitoring returned empty bottle counts.
Intervention code [1] 323038 0
Treatment: Other
Comparator / control treatment
During the placebo/control treatment participants will receive a daily dose of 100ml of Modex, containing 240mg Papin, 300mg Sodium chloride, 175mg Aloe Vera, and 169mg Procyanidins (Modex formula minus Pycnogenol) for 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 330674 0
Change in 30 minute cycling test:
- average power output (W)
- perceived exertion
Timepoint [1] 330674 0
1) Pre-supplement 2) 4 weeks post supplement
Primary outcome [2] 330822 0
Changes in real time muscle oxygenation during exercise using a Moxy Monitor
Timepoint [2] 330822 0
1) Pre-supplement 2) 4 weeks post supplement
Secondary outcome [1] 407148 0
Changes in C-reactive protein (mg/L) as determine by blood analysis following fitness tests
Timepoint [1] 407148 0
1) Pre-supplement 2) 4 weeks post supplement

Eligibility
Key inclusion criteria
1. Adults between the ages of 18-45
2. Actively participate in cycling (minimum 3 sessions per week)
3. competitive C grade rider or higher, completing approximately 200 km or more per week
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Are pregnant and/or breastfeeding.
2) Present with a history of treatment for metabolic disease (e.g., diabetes or cardiovascular disease).
3) Are currently using any prescription medication which could impact on inflammatory pathways (e.g., Warfarin, aspirin, ibuprofen [nurofen]).
4) Have any medical contraindications to exercise.
5) Are currently injured.

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)
Numbers 1-20 will be placed in an envelope. Upon enrolment in the trial, an envelope will be randomly selected and given to the individual. Prior to this, a random sequence of the numbers 1-20 will be generated, with odd numbers (in the sequence) being placebo and even numbers (in the sequence) being Modex
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. https://www.random.org/sequences/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A linear mixed model using restricted estimate maximum likelihood estimation (REML) will analyse the effect of the treatment (factor with 2 levels: pycnogenol, placebo) over time (factor with 4 levels: visit 2-3), adjusting for baseline values of the response variable (visit 1: continuous covariate) for potential sequence/carry-over effects (factor with 2 levels: AB/BA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310906 0
Commercial sector/Industry
Name [1] 310906 0
Arborvitae Health & Wellbeing Pty Ltd
Country [1] 310906 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd & Kingsbury Drive,
Bundoora
Melbourne Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 312191 0
Commercial sector/Industry
Name [1] 312191 0
Arborvitae Health & Wellbeing Pty Ltd
Address [1] 312191 0
10 Gordon St, Bankstown, NSW 2200
Country [1] 312191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310468 0
La Trobe University
Ethics committee address [1] 310468 0
Ethics committee country [1] 310468 0
Australia
Date submitted for ethics approval [1] 310468 0
04/04/2022
Approval date [1] 310468 0
07/06/2022
Ethics approval number [1] 310468 0
HEC22087

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

Contacts
Principal investigator
Name 117770 0
Dr Chris van der Poel
Address 117770 0
Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 117770 0
Australia
Phone 117770 0
+61 3 9479 5166
Fax 117770 0
Email 117770 0
c.vanderpoel@latrobe.edu.au
Contact person for public queries
Name 117771 0
Chris van der Poel
Address 117771 0
Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 117771 0
Australia
Phone 117771 0
+61 3 9479 5166
Fax 117771 0
Email 117771 0
c.vanderpoel@latrobe.edu.au
Contact person for scientific queries
Name 117772 0
Chris van der Poel
Address 117772 0
Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia
Country 117772 0
Australia
Phone 117772 0
+61 3 9479 5166
Fax 117772 0
Email 117772 0
c.vanderpoel@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all of the individual participant data collected during the trial will be shared
When will data be available (start and end dates)?
Immediately following publication with no end date
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access is subject to approval by principal investigator which can be requested by email (c.vanderpoel@latrobe.edu.au)


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.