ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000510741

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 CrossFitters.

Scientific title

Evaluation of the effects of supplementation with Pycnogenol (French Pinus pinaster bark extract) on exercise performance in a population of CrossFitters: A single blind, crossover trial.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1275-2235

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

exercise performance

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A double blind crossover trial, placebo controlled study will be conducted in which male and female subjects who actively participate in CrossFit, 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 2 weeks. Following a 2-week washout period, participants will repeat this process supplemented with the opposite intervention.

Prior to and after each of the 2-week supplement periods, participants will have a VO2 max test, 1 rep max (1RPM) back squat strength test and an anaerobic capacity Wingate test conducted at La Trobe University strength and conditioning gym (Bundoora campus), supervised by qualified exercise physiologists. These 4 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 4 hours.

To monitor adherence, we will be monitoring returned empty bottle counts.

Intervention code [1]

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 2 weeks.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in muscle strength as determined by weight (kgs) performed on the 1 rep maximum back squat

Timepoint [1]

1) Pre-supplement period 1
2) 2 weeks post supplement period 1
3) Pre-supplement period 2 (4 weeks post enrolment)
4) 2 weeks post supplement period 2 (6 weeks post enrolment)

Primary outcome [2]

Changes in anaerobic performance as determined by peak power (Watts/kg body weight) performed on the Wingate anaerobic fitness test

Timepoint [2]

1) Pre-supplement period 1
2) 2 weeks post supplement period 1
3) Pre-supplement period 2 (4 weeks post enrolment)
4) 2 weeks post supplement period 2 (6 weeks post enrolment)

Primary outcome [3]

Changes in the volume of oxygen consumption (ml/kg/min) as determined by a Vo2 max test performed on a cycle ergometer

Timepoint [3]

1) Pre-supplement period 1
2) 2 weeks post supplement period 1
3) Pre-supplement period 2 (4 weeks post enrolment)
4) 2 weeks post supplement period 2 (6 weeks post enrolment)

Secondary outcome [1]

Changes in C-reactive protein (mg/L) as determine by blood analysis following fitness tests

Timepoint [1]

1) Pre-supplement period 1
2) 2 weeks post supplement period 1
3) Pre-supplement period 2 (4 weeks post enrolment)
4) 2 weeks post supplement period 2 (6 weeks post enrolment)

Eligibility

Key inclusion criteria

1. Adults between the ages of 18-45
2. Actively participate in CrossFit (minimum 2 sessions per work)

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

Crossover

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 2-4), 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

Recruiting

Date of first participant enrolment

Anticipated

15/07/2022

Actual

11/09/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Arborvitae Health & Wellbeing Pty Ltd

Address [1]

10 Gordon St, Bankstown, NSW 2200

Country [1]

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]

Commercial sector/Industry

Name [1]

Arborvitae Health & Wellbeing Pty Ltd

Address [1]

10 Gordon St, Bankstown, NSW 2200

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe Unveristy

Ethics committee address [1]

Plenty Rd & Kingsbury Drive,
Bundoora
Melbourne Victoria 3086
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2022

Approval date [1]

07/06/2022

Ethics approval number [1]

HEC22087

Summary

Brief summary

Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training.

Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise.

Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training.

Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained CrossFitters.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Chris van der Poel

Address

Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia

Country

Australia

Phone

+61 3 9479 5166

Fax

c.vanderpoel@latrobe.edu.au

Contact person for public queries

Name

Chris van der Poel

Address

Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia

Country

Australia

Phone

+61 3 9479 5166

Fax

c.vanderpoel@latrobe.edu.au

Contact person for scientific queries

Name

Chris van der Poel

Address

Department of Microbiology, Anatomy, Physiology & Pharmacology
Health Sciences 2
La Trobe University
Plenty Rd & Kingsbury Dr,
Bundoora
Melbourne Victoria 3086
Australia

Country

Australia

Phone

+61 3 9479 5166

Fax

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.

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