Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000302459
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effects of pine back extract and black currants on the athletic performance of endurance athletes.
Scientific title
Investigating the efficacy of pine bark extract and black currant supplements on athletic performance in endurance athletes.
Secondary ID [1] 313990 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise Endurance 336716 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333217 333217 0 0
Other physical medicine / rehabilitation
Musculoskeletal 333477 333477 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two interventional groups, both of which will receive one of two different supplements for 2 weeks in total. The two supplements are: Zestt Wellness's Liquid Breathe +, and Plasmaide.


1. Breathe + by Zestt Wellness
Actives: Boysenberry and blackcurrant, japonica saphora’s flavonoid quercetin, and
probiotic BLISK12.
Full Ingredient List: Boysenberry and blackcurrant, japonica saphora’s flavonoid quercetin,
and probiotic BLISK12.
Dosage: 35mL per day, 1-2 hours before exercise, containing:
Anthocyanins (boysenberry and blackcurrant): 2625 mg, Quercetin: 175 mg, Chelated zinc: 5.25 mg, UMF 20+ Manuka honey: 175 mg.

2. Plasmaide by Plasmaide:
Actives: Pinus pinaster stem bark extract.

Full Ingredient List: Water, Emulsifier (Xanthan Gum) (E415), Sodium Chloride, Black
Carrot Extract, Southern Fulvic Acid, Watermelon Flavour, Acidity Regulator (Citric Acid)
(E330), Pine Bark Extract, Preservatives (E202, E211), Sweetener (Steviol Glycosides).
Dosage: 2 packets (90 mL total) per day (1 packet 30 to 60 minutes before and after
exercise). Pinus pinaster stem bark extract equivalent to dry stem bark 520g/90 mL (1
serving: 260g/45ml).

Participants will be asked to continue to undertake their usual and prescribed training programs throughout the study.

Before VO2max and submaximal exercise testing, the participant will be well rested and would have refrained from intense exercise for at least 24 hours. All four exercise tests will be conducted at similar times of the day for each participant. They will be normally hydrated and would have refrained from taking any non-habituated stimulants, supplements, or medications, and refrain from eating a large meal within 2-3 hours of the test. Participants will also be asked to abstain from vape or cigarette smoking 4 hours before exercise, along with alcohol 12 hours before each test. Patients will perform all four exercise tests in their daily habituated state to preserve normalcy and establish a reliable baseline for any exercise testing. This includes preserving normal sleep routines, medications, and food and coffee consumption. These requirements will be advised during recruitment, prior to any exercise testing.

Participants will be asked to return their empty bottles of supplement upon their final exercise test.
Intervention code [1] 330576 0
Treatment: Other
Comparator / control treatment
Participants will act as their own baseline/control before and after supplementation.
Control group
Active

Outcomes
Primary outcome [1] 340791 0
Maximal oxygen uptake (VO2max)
Timepoint [1] 340791 0
Week 1: Baseline (Pre-supplementation). Week 2: Baseline (Pre-supplementation). Week 3: Acute effect (After single supplement dose). Week 5: Chronic effect (After 2 weeks of daily supplementation).
Primary outcome [2] 340963 0
Submaximal substrate utilization.
Timepoint [2] 340963 0
Week 1: Baseline (Pre-supplementation). Week 2: Baseline (Pre-supplementation). Week 3: Acute effect (After single supplement dose). Week 5: Chronic effect (After 2 weeks of daily supplementation).
Secondary outcome [1] 445092 0
Changes in lung function
Timepoint [1] 445092 0
Week 1: Baseline (Pre-supplementation). Week 2: Baseline (Pre-supplementation). Week 3: Acute effect (After single supplement dose). Week 5: Chronic effect (After 2 weeks of daily supplementation).
Secondary outcome [2] 445623 0
Changes in muscle oxygenation
Timepoint [2] 445623 0
Week 1: Baseline (Pre-supplementation). Week 2: Baseline (Pre-supplementation). Week 3: Acute effect (After single supplement dose). Week 5: Chronic effect (After 2 weeks of daily supplementation).
Secondary outcome [3] 445624 0
Muscle nitric oxide
Timepoint [3] 445624 0
Week 1: Baseline (Pre-supplementation). Week 2: Baseline (Pre-supplementation). Week 3: Acute effect (After single supplement dose). Week 5: Chronic effect (After 2 weeks of daily supplementation).

Eligibility
Key inclusion criteria
1. Endurance Athletes:
• Cyclists (Road, Track, or Mountain bike)
• Triathletes/Duathletes
• Long Distance Runners

a) Endurance Discipline Requirement:
Athletes competing within A or B grades regionally or nationally in endurance disciplines such as cycling, triathlon, duathlon, or long-distance running will be selected to ensure consistency. Amateurs with low baseline aerobic capacities often show more significant improvements in VO2max, potentially skewing the results. Selecting athletes at this competitive level provides a more reliable baseline for evaluating the effects of administered supplements.
b) Exercise Testing Modality:
All athletes will complete exercise testing on a cycle ergometer. This ensures uniformity in testing procedures and facilitates direct comparison of results.

2. Biological Sex:
• Biological Male
• Biological Female

a) Biological Sex:
Including an even spread of biological males and females ensures a comprehensive
understanding of supplement effects across sexes. Sex differences in metabolism,
cardiovascular function, and exercise response may influence study outcomes, making
it essential to include a diverse participant pool. Aiming for equal representation of male
and female participants enhances validity by reducing the potential for bias and ensures
a balanced assessment of supplement efficacy across sexes
b) Menstruation Monitoring:
Female participants will be selected based on menstrual status. Regular menstruation
indicates normal endocrine function, so these participants will be included in this study.
To ensure consistency in hormonal fluctuations, menstrual cycles of female participants
will be monitored, and testing will be conducted at consistent phases of their cycles. Any
non-menstruating females on birth control will also be included but will not require the
same monitoring as they will observe a consistent hormonal status throughout the study
period.

3. Age:
• Males: 20-50
• Females: 20-35

a) Cardiovascular Risk Mitigation:
Setting age limits for males (20-50) and females (20-35) reduces the risk of cardiovascular complications during exercise testing. Individuals above these age brackets may have underlying cardiovascular conditions or decreased exercise tolerance, increasing the likelihood of adverse events during physical exertion. This age limit also helps to exclude any biological females in perimenopause, who may exhibit hormonal fluctuations affecting exercise performance.
b) Aerobic Fitness Control:
Age can significantly impact aerobic fitness, so including participants within specific age ranges allows for better control of age-related physiological changes. This ensures a more homogeneous sample and facilitates accurate comparison of results across individuals.

4. Ability to Provide Informed Consent
• 4 total VO2max tests
• 3 total submaximal exercise tests
• 3 total spirometry tests
• 2 total diffusion capacity tests
• Daily supplementation for 2 weeks

a) Ability to Provide Informed Consent:
Participants must possess the capacity to understand and consent to the requirements of the study, including exercising to failure in four total VO2max tests, two diffusion capacity tests in total (2 weeks apart), and taking a daily supplement for 2 weeks. This requires comprehension of the purpose, procedures, potential risks, and benefits of the study. Providing informed consent demonstrates the participant's willingness to engage in the study voluntarily and signifies their understanding of the protocol's demands. Ensuring participants can provide informed consent upholds ethical research standards, protects participant autonomy, and facilitates adherence to the study's rigorous protocol, promoting the validity and reliability of the research findings.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Antioxidant Supplementation:
a) Exclusion of Participants Supplementing with Antioxidants:
Individuals currently supplementing with antioxidants, including green tea and similar
substances, are excluded unless willing to abstain from supplementation for a specified
washout period (typically 3-4 weeks). This exclusion is implemented to avoid potential
interference of antioxidant supplementation with the intended effects of the
administered supplement on aerobic fitness.

2. Medical Considerations:
a) Exclusion of Participants with Medical Conditions:
Individuals with pre-existing medical conditions that could affect exercise performance or safety are excluded from participation. These will be determined based on responses to the Physical Activity Readiness Questionnaire 2024 (Warburton et al., 2011). This ensures that participants are free from conditions that may confound study results or pose increased risk during physical activity.
b) Exclusion of Pregnant Participants:
Pregnancy introduces physiological changes that may affect exercise tolerance, cardiovascular responses, and hormonal status. Excluding pregnant individuals ensures participant safety and minimizes potential risks associated with exercise testing during pregnancy.
c) Recent Major Illness or Surgery:
Excluding individuals who have recently undergone major surgery or experienced significant illness ensures that participants are in stable health condition and minimizes potential complications during exercise testing.
d) Medication Use:
Screening for medication use, beyond hormonal therapy and antioxidants, may be
necessary to identify potential medications that could influence exercise performance or
physiological responses. In particular, asthma medications will be excluded as they can
interfere with lung function measures such as spirometry and diffusion capacity.
Excluding participants on certain medications helps maintain the integrity of the study
results.

3. Inability To Provide Informed Consent
a) Exclusion of Participants unable to provide informed consent:
Participants must possess the capacity to comprehend and consent to the VO2max test protocol, agree to undergo two blood draws, multiple finger or ear lobe pricks, and perform exercise until failure. This requires understanding the purpose, procedures, potential risks, and benefits of the test. Inability to provide informed consent may stem from cognitive impairment, language barriers, or legal incapacitation, preventing individuals from fully understanding and consenting to the requirements of the study.
Excluding participants unable to provide informed consent safeguards ethical research conduct and ensures participant autonomy and welfare. It also guarantees adherence to the study's rigorous protocol, which includes blood sampling and maximal exercise testing.

4. Biological Sex
a) Exclusion of Hormonal Therapy:
Excluding individuals on hormonal therapy ensures that the effects of these medications
on physiological parameters, including VO2max, are minimised. Hormonal therapies can
influence metabolism, cardiovascular function, and exercise performance, potentially
confounding the study results. Females on oral contraceptives will be accepted for the
study. However, athletes on anabolic or steroidal agents will not be included to avoid any
potential confounding effects on the study outcomes.
b) Menstruation Monitoring:
Female participants who have lost their periods due to conditions such as Relative
Energy Deficiency in Sport (RED-S) will be excluded from the study to maintain
homogeneity in the sample and avoid potential confounding effects on study outcomes.

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)
Participants will be randomly assigned to one of two supplement groups. This randomisation will be conducted by a researcher who is not involved in participant recruitment, testing, or data collection and analysis. The allocation will remain concealed until after testing and analysis is fully completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated into one of the two supplement groups by a research who will not be involved in any recruitment, testing or analysis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2025
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
26
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 26901 0
New Zealand
State/province [1] 26901 0
Otago

Funding & Sponsors
Funding source category [1] 318492 0
Commercial sector/Industry
Name [1] 318492 0
Zestt Wellness
Country [1] 318492 0
New Zealand
Funding source category [2] 318508 0
Commercial sector/Industry
Name [2] 318508 0
Plasmaide
Country [2] 318508 0
Australia
Primary sponsor type
University
Name
University of Otago, Department of Physiology
Address
Country
New Zealand
Secondary sponsor category [1] 320886 0
University
Name [1] 320886 0
University of Otago, School of Physical Education
Address [1] 320886 0
Country [1] 320886 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317102 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 317102 0
Ethics committee country [1] 317102 0
New Zealand
Date submitted for ethics approval [1] 317102 0
17/06/2024
Approval date [1] 317102 0
31/07/2024
Ethics approval number [1] 317102 0
H24/0124

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

Contacts
Principal investigator
Name 140002 0
Prof Alison Heather
Address 140002 0
University of Otago, Departnemt of Physiology, 270 Great King Street, Dunedin, 9016
Country 140002 0
New Zealand
Phone 140002 0
+64 211944550
Fax 140002 0
Email 140002 0
[email protected]
Contact person for public queries
Name 140003 0
Emma Sutherland
Address 140003 0
University of Otago, Departnemt of Physiology, 270 Great King Street, Dunedin, 9016
Country 140003 0
New Zealand
Phone 140003 0
+64 277365550
Fax 140003 0
Email 140003 0
[email protected]
Contact person for scientific queries
Name 140004 0
Emma Sutherland
Address 140004 0
University of Otago, Departnemt of Physiology, 270 Great King Street, Dunedin, 9016
Country 140004 0
New Zealand
Phone 140004 0
+64 277365550
Fax 140004 0
Email 140004 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:
• Qualified researchers affiliated with academic institutions, government agencies, or industry partners involved in sports science, metabolism, or mitochondrial research. Requests must be accompanied by a data-sharing agreement.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data, including VO2max, submaximal exercise data, respiratory exchange ratio (RER), spirometry, diffusion capacity, nitric oxide and muscle oxygenation data. Data dictionaries and metadata will also be provided.

What types of analyses could be done with individual participant data?
• The data will be available for secondary analyses, meta-analyses, and systematic reviews related to endurance performance, metabolism, and supplementation efficacy. Reuse for commercial purposes will require separate authorization.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available after study completion and publication of primary findings. Expected availability: September 2025. Data will remain available for at least 5 years after publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Interested researchers can request access by contacting the principal investigator at [email protected]. Data requests will be reviewed by the research ethics committee before approval. Approved researchers will receive access via a secure institutional repository (e.g., University of Otago’s data archive)

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24556Ethical approval    UOHEC H_ApprovalLetter_6339_16_Sep_2024 (1).pdf
24557Ethical approval    17. HRS Letter of Approval 02122.pdf
24558Study protocol    Proposal and Full Protocol.pdf
24559Informed consent form    Emma Sutherland Master's Project Consent Form.pdf



Results publications and other study-related documents

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