Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12622001277730
Ethics application status
Approved
Date submitted
20/09/2022
Date registered
29/09/2022
Date last updated
29/09/2022
Date data sharing statement initially provided
29/09/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of acute vs. chronic blackcurrant extract supplementation on cycling performance
Query!
Scientific title
The effects of acute vs. chronic blackcurrant extract supplementation on cycling performance, physiology and respiration in trained male and female cyclists.
Query!
Secondary ID [1]
307744
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Exercise capacity
327680
0
Query!
Condition category
Condition code
Musculoskeletal
324765
324765
0
0
Query!
Normal musculoskeletal and cartilage development and function
Query!
Respiratory
324800
324800
0
0
Query!
Normal development and function of the respiratory system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Subjects will consume blackcurrant extract (BE) powder administered in opaque, purple, berry flavoured gelatin capsules at a dose of 4.3 mg/kg body weight. Supplementation will be 60 minutes before exercise for the acute trial and for 7 days (one dose per day taken orally in gelatin capsules) before the next exercise trial. The number of placebo capsules will match the quantity needed to administer a 4.3 mg/kg body weight dose of BE. Subjects will be oversupplied with capsules and a countback will be done to ensure supplementation adherence. The exercise protocol is an incremental V'O2 max test of 3 minute stages increasing 30 watts every 3 minutes until exhaustion and/or an inability to maintain a cycling cadence of > 75 rpm. Following the completion of the incremental test, subjects will have a 15 minute rest, and then be required to complete a maximal 4 km time trial as fast as possible. All cycling tests will be performed on a calibrated cycle ergometer. Subjects will then repeat the trial after consuming an acute dose of the alternative supplement (BC/PL) and then consume a daily dose for a period of 7 days before completing the exercise protocol again. There is a 7-day washout period between chronic and acute supplementation trials.
Query!
Intervention code [1]
324461
0
Treatment: Other
Query!
Comparator / control treatment
Placebo will be an equivalent dose of dextrose powder administered in the same purple, berry flavoured, gelatin capsules at a quantity that matches the BC volume.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
332587
0
Cycling time trial performance time measured by the cycle ergometer's software (RacerMate Inc, WA, USA).
Query!
Assessment method [1]
332587
0
Query!
Timepoint [1]
332587
0
Immediately post completion of the 4 km time trial.
Query!
Primary outcome [2]
332588
0
Ventilatory threshold will be calculated from metabolic data obtained from a calibrated metabolic system (Metamax, Cortex, Leipzig, Germany).
Query!
Assessment method [2]
332588
0
Query!
Timepoint [2]
332588
0
At the completion of the incremental cycling test
Query!
Secondary outcome [1]
413994
0
Respiratory function will be assessed with spirometry testing for forced vital capacity (FVC), forced expiratory volume (FEV1), peak expiratory flow (PEF) according to the guidelines of the American Thoracic Society (2019), using a digital spirometer interfaced to a computer (Medikro Pro, Kuopio, Finland).
Query!
Assessment method [1]
413994
0
Query!
Timepoint [1]
413994
0
Spirometry testing will occur 10 minutes prior to exercise testing and 5 minutes post completion of the incremental ramp test and 5 minutes post the 4 km time trial.
Query!
Eligibility
Key inclusion criteria
Trained male and female 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 over 16 years of age
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
None
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque numbered containers
Computer generated randomisation (randomizer.org)
Allocation administered by a third party not involved with the research/study.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation (randomizer.org)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/10/2022
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
16/01/2023
Query!
Actual
Query!
Date of last data collection
Anticipated
20/02/2023
Query!
Actual
Query!
Sample size
Target
24
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
25016
0
New Zealand
Query!
State/province [1]
25016
0
Waikato and Hawkes Bay
Query!
Funding & Sponsors
Funding source category [1]
312013
0
University
Query!
Name [1]
312013
0
University of Auckland
Query!
Address [1]
312013
0
Faculty of Medical and Health Sciences (FMHS)
85 Park Road
Grafton
Auckland
1023
Query!
Country [1]
312013
0
New Zealand
Query!
Primary sponsor type
University
Query!
Name
University of Auckland
Query!
Address
Faculty of Medical and Health Sciences (FMHS)
85 Park Road
Grafton
Auckland
1023
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
313511
0
Individual
Query!
Name [1]
313511
0
Dr Andrea Braakhuis
Query!
Address [1]
313511
0
Faculty of Medical and Health Sciences (FMHS)
85 Park Road
Grafton
Auckland
1023
Query!
Country [1]
313511
0
New Zealand
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
311433
0
Central Health and Disability Ethics Committee
Query!
Ethics committee address [1]
311433
0
Ministry of Health
133 Molesworth Street
Wellington
6011
Query!
Ethics committee country [1]
311433
0
New Zealand
Query!
Date submitted for ethics approval [1]
311433
0
12/08/2022
Query!
Approval date [1]
311433
0
20/09/2022
Query!
Ethics approval number [1]
311433
0
2022 EXP 13363
Query!
Summary
Brief summary
The mechanisms underlying performance increases following anthocyanin supplementation have not been elucidated. However, a review examining dietary anthocyanin intake postulates that performance improvements may be mediated by increases in endothelial nitric oxide and subsequent enhanced muscle blood flow (Cook & Williams, 2019). In addition, the same review highlighted that most studies reporting performance benefits utilised a chronic BE loading regime but also provided an acute dose immediately before exercise, therefore raising the question if any performance benefits were due to the intake of the final acute dose, or a result of chronic loading. Due to the lack of research examining the effects of acute versus chronic BE supplementation on exercise performance the primary aim of this research was to examine the effects of a single acute dose of blackcurrant extract (BE) on exercise performance compared to 7-day supplementation. A secondary aim is to determine if any respiratory benefits exist with supplementation, and finally if BE supplementation (acute or chronic) in healthy exercising individuals improves respiratory function. The proposed dose of blackcurrant extract is 4.3 mg/kilogram body weight. Subjects will take an acute dose of either placebo or BE 60 minutes before completing an incremental cycling test to exhaustion, followed by 15 minutes rest, and then complete a 4 km time trial. BE and PL will be administered in purple, berry flavoured gelatin capsules. Following the acute trial, subjects will supplement for 7-days and return to the lab to complete the testing again. A 7-day washout will occur before completing the protocols again but consuming the alternative supplement. Two familiarisation trials will be completed to calculate the coefficient of variation (CV ) of the exercise protocol and for subjects to become accustomed to the protocols and testing, thereby reducing any potential learning effects. There will be no supplementation at the familiarisation trials.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
121078
0
Ms Lillian Morton
Query!
Address
121078
0
University of Auckland
Faculty of Medical and Health Sciences
85 Park Road,
Grafton
Auckland
1203
Query!
Country
121078
0
New Zealand
Query!
Phone
121078
0
+64 0275190374
Query!
Fax
121078
0
Query!
Email
121078
0
[email protected]
Query!
Contact person for public queries
Name
121079
0
Ms Lillian Morton
Query!
Address
121079
0
University of Auckland
Faculty of Medical and Health Sciences
85 Park Road,
Grafton
Auckland
1203
Query!
Country
121079
0
New Zealand
Query!
Phone
121079
0
+64 0275190374
Query!
Fax
121079
0
Query!
Email
121079
0
[email protected]
Query!
Contact person for scientific queries
Name
121080
0
Ms Lillian Morton
Query!
Address
121080
0
University of Auckland
Faculty of Medical and Health Sciences
85 Park Road,
Grafton
Auckland
1203
Query!
Country
121080
0
New Zealand
Query!
Phone
121080
0
+64 0275190374
Query!
Fax
121080
0
Query!
Email
121080
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF