Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001198718
Ethics application status
Approved
Date submitted
10/08/2022
Date registered
7/09/2022
Date last updated
7/09/2022
Date data sharing statement initially provided
7/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a blackcurrant powder blend on repeated high-intensity cycling performance, attention and lung function under pollution exposure in highly trained male cyclists.
Scientific title
Effects of a blackcurrant Nootropic powder on repeated high-intensity cycling performance, cognition and respiratory function under ozone exposure in highly trained male cyclists.
Secondary ID [1] 304028 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung function 321658 0
Cognition 321659 0
Condition category
Condition code
Respiratory 319408 319408 0 0
Normal development and function of the respiratory system
Neurological 324635 324635 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Blackcurrant powder supplementation and ozone exposure. Healthy participants will supplement with a proprietary blackcurrant powder (Arepa) before undergoing an exercise trial under conditions of ozone exposure. Participants will consume either blackcurrant (BC) or placebo (PL) for seven days prior to completing a cycling protocol on a cycle ergometer in a chamber with ozone set to 0.25 ppm. Treatments (BC or PL) will be administered in purple, berry flavoured gelatine capsules at a dose of 4.3 mg/kg body weight. Subjects will take their prescribed dose daily orally for a period of 7 days before reporting to the lab for testing. Participants will be oversupplied with capsules and a countback will be used to determine adherence to the supplement protocol. Participants will complete a preload protocol of 10 min @ 50%, 10 min @ 60% and 5 min @ 70% peak power output (PPO) followed by a 10 min rest. They will then complete a 4 km time trial (TT) as fast as possible. The PPO for the preload will be obtained from a VO2 max test conducted at the first visit and familiarisation trial. There is a 2-week washout before the next supplementation period.
All exercise sessions (with the exception of the VO2 and familiaristaion) will be performed under ozone (0.25 ppm) conditions. Participants will be monitored at all times throught the entire study progress. Cycling data (power, distance, cadence, time) will be automatically recorded by the ergometers associated software). Metabolic data will be collected using breath-by-breath analysis using a metabolic cart.
Intervention code [1] 320376 0
Prevention
Comparator / control treatment
Colour, taste and volume matched powder without Vitamin C and polyphenol content.
Control group
Placebo

Outcomes
Primary outcome [1] 327554 0
Performance time - 4 km time trial time. recorded by the cycle ergometer (Velotron)
Timepoint [1] 327554 0
Immediately post - time to complete the 4 km TT.
Primary outcome [2] 327555 0
Fraction expired Nitric Oxide (FeNO) measured by a portable FeNO device (Bedfont).
Change in FeNO levels from pre to post, and also expressed as % change.
Timepoint [2] 327555 0
Pre ozone exposure
5 min post and 10 min post 4 km TT completion
Primary outcome [3] 332409 0
Respiratory Function (FVC, FEV1) measured by digital spirometer interfaced to a computer (MediKro).
Changes in lung function will be analysed as raw values and % change pre to post.
Timepoint [3] 332409 0
Pre exercise and ozone exposure
10 minutes and 15 minutes Post the 4 km TT
Secondary outcome [1] 395640 0
BDNF (brain derived neurotropin factor) (measured in serum)
Changes pre vs post
Timepoint [1] 395640 0
Sample collected pre exposure and exercise and 5 minutes post 4 km TT completion
Secondary outcome [2] 413394 0
Plasma cytokines - IL-6, IL-10, TNF-a.
Change between cytokines from pre to post.
Timepoint [2] 413394 0
Blood sample collection pre exposure and 5 minutes post the completion of the 4 km TT.
Secondary outcome [3] 413395 0
Skeletal muscle oxygenation (SmO2 %) measured via near-infrared spectroscopy (NIRS) device (Moxy) attached to the quadricep muscle of the dominant leg.
Timepoint [3] 413395 0
Measured continuosly throughout the preload, recovery between preload and 4 km TT, during the 4 km TT and 10 min post 4 km TT.
Secondary outcome [4] 413396 0
Stroop as a measure of executive function. Measured using an ipad (EncephelApp). Correct responses, speed of responses, total errors are variables of interest.
Timepoint [4] 413396 0
Pre exposure, post preload and post 4 km TT.
Secondary outcome [5] 413397 0
Serial Subtraction tasks (3's and 7's). Using pen and paper method. Correct responses, speed of responses, total errors are variables of interest.
Timepoint [5] 413397 0
Measured pre exposure and post 4 km TT
Secondary outcome [6] 413552 0
Mean power (watts) of the 4 km TT measured continuously by the cycle ergometer's associated software.
Timepoint [6] 413552 0
Continuosly through the TT measured by the associated software of the ergometer

Eligibility
Key inclusion criteria
Highly-trained male cyclists with a training history of > 2 years, no chronic health conditions or respiratory conditions (i.e. asthma or exercise-induced asthma or breathlessness), no acute respiratory illness within the last month, no medications that affect respiratory, cardiovascular or immune function, and be restricted to males over 18 years of age.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by off-site holder of allocation order. Powder in opaque capsules matched by quantity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/01/2022
Date of last participant enrolment
Anticipated
Actual
20/06/2022
Date of last data collection
Anticipated
Actual
27/07/2022
Sample size
Target
12
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 24942 0
New Zealand
State/province [1] 24942 0
Waikato

Funding & Sponsors
Funding source category [1] 308411 0
Government body
Name [1] 308411 0
High Value Nutrition (HVN)
Country [1] 308411 0
New Zealand
Primary sponsor type
Government body
Name
High Value Nutrition
Address
Building 505
85 Park Road
Grafton, 1023
Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 309244 0
University
Name [1] 309244 0
University of Auckland
Address [1] 309244 0
85 Park Road
Grafton
Auckland 1023
New Zealand
Country [1] 309244 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308373 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308373 0
Ethics committee country [1] 308373 0
New Zealand
Date submitted for ethics approval [1] 308373 0
21/03/2021
Approval date [1] 308373 0
19/04/2021
Ethics approval number [1] 308373 0
21/NTB/68

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

Contacts
Principal investigator
Name 110482 0
Ms Lillian Morton
Address 110482 0
University of Auckland,
Faculty of Medical and Health Sciences (FMHS),
85 Park Road,
Grafton,
Auckland, 1023
Country 110482 0
New Zealand
Phone 110482 0
+64 275190374
Fax 110482 0
Email 110482 0
[email protected]
Contact person for public queries
Name 110483 0
Lillian Morton
Address 110483 0
University of Auckland,
FMHS,
85 Park Road,
Grafton,
Auckland, 1023
Country 110483 0
New Zealand
Phone 110483 0
+64 275190374
Fax 110483 0
Email 110483 0
[email protected]
Contact person for scientific queries
Name 110484 0
Lillian Morton
Address 110484 0
University of Auckland,
FMHS,
85 Park Road,
Grafton,
Auckland, 1023
Country 110484 0
New Zealand
Phone 110484 0
+64 275190374
Fax 110484 0
Email 110484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data can be requested upon request by contacting the principal investigator. In the interest of maintaining subject privacy, individual data will not be available.


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
SourceTitleYear of PublicationDOI
EmbaseThe Effects of Polyphenol Supplementation on BDNF, Cytokines and Cognition in Trained Male Cyclists following Acute Ozone Exposure during High-Intensity Cycling.2024https://dx.doi.org/10.3390/nu16020233
N.B. These documents automatically identified may not have been verified by the study sponsor.