Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001597886
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
22/11/2021
Date last updated
11/01/2023
Date data sharing statement initially provided
22/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of anthocyanins on exercise-induced bronchoconstriction
Scientific title
Effect of anthocyanins on lung hyper-responsiveness in adults aged 18 to 40 suffering from exercise-induced bronchoconstriction
Secondary ID [1] 305520 0
Nil known
Universal Trial Number (UTN)
U1111-1270-8530
Trial acronym
ANEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced bronchoconstriction 324042 0
Condition category
Condition code
Respiratory 321549 321549 0 0
Asthma
Respiratory 321792 321792 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 321793 321793 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be six capsules of CurraNZ New Zealand blackcurrant extract capsules (manufactured in Surrey, United Kingdom), the equivalent to 105 mg anthocyanins per capsule. The dosage will equal 630 mg anthocyanin daily for the 28 days of intervention. Safety profiles conducted o/s have shown no adverse effects and a toxicity LD50 = 2,000 mg/kg. Previous studies have not reported adverse effects from this product. Packaging will be divided into individual mylar bags for each day. At the end of the intervention, the return of the empty bags will be used to monitor adherence. The 14-day washout period has been calculated via the recommendation of 10x the elimination half-life. The half-life for anthocyanin ranges between 12 and 51 hours The 14-day washout period has been calculated via the recommendation of 10x the elimination half-life. The half-life for anthocyanin ranges between 12 and 51 hours.
Intervention code [1] 322014 0
Treatment: Other
Comparator / control treatment
The placebo will be capsules containing microcrystalline cellulose coloured with charcoal.
The same number of capsules will be used for both the intervention and the placebo; with packaging of both products being identical to remove ability to differentiate between placebo and intervention. As this product does not digest in the human body, no wash out period required.
Control group
Placebo

Outcomes
Primary outcome [1] 329314 0
Data will be presented as mean and standard deviations. Forced expiratory volume in 1 second following eucapnic voluntary hyperpnoea assessed using spirometry to determine outcome of intervention.
Timepoint [1] 329314 0
28 days from baseline to end of intervention period.
FEV1 will be assessed on day 1 (baseline) and day 28 (primary endpoint) of the intervention. Following 14 days washout this process will be repeated on day 42 and Day 70.
Secondary outcome [1] 402109 0
Monitoring blood inflammatory markers. 20ml whole blood will be collected at baseline, 15 min and 60 min after EVH. Analysis will include a full blood count, Immunoglobulin E, T cells, tumour necrosis factor A and B and C-reactive protein.
Timepoint [1] 402109 0
Blood inflammatory markers will be assessed on day 0 and day 28 of the intervention. After 14 days washout, blood inflammatory markers will be assessed on day 42 and day 70.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Aged between 18 and 40 years of age.
• BMI (kg/m2) 18-35
• Exercise-induced bronchoconstriction (EIB) – Physician-diagnosed EIB, Fall >10% forced expiratory volume in 1 second (FEV1) following eucapnic voluntary hyperpnoea (EVH).
• Medications -Asthma medications
• Chronic diseases - Healthy individuals except diagnosis of EIB
• Smoking - Non-smoker
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

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)
Sealed aluminium mylar bags.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using repeated-measures ANOVA and Bonferroni-adjusted paired t tests. Statistical significance will be set at P-value <0.05.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/01/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
29/08/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 35638 0
4305 - Ipswich
Recruitment postcode(s) [2] 35639 0
4306 - Ripley
Recruitment postcode(s) [3] 35640 0
4300 - Springfield
Recruitment postcode(s) [4] 35641 0
4301 - Redbank
Recruitment postcode(s) [5] 35642 0
4303 - Riverview
Recruitment postcode(s) [6] 35643 0
4304 - Booval

Funding & Sponsors
Funding source category [1] 309889 0
University
Name [1] 309889 0
University of Southern Queensland
Country [1] 309889 0
Australia
Primary sponsor type
Individual
Name
Lauren Brook
Address
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country
Australia
Secondary sponsor category [1] 311018 0
Individual
Name [1] 311018 0
Dean Mills
Address [1] 311018 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4301
Country [1] 311018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309613 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [1] 309613 0
Ethics committee country [1] 309613 0
Australia
Date submitted for ethics approval [1] 309613 0
25/10/2021
Approval date [1] 309613 0
21/12/2021
Ethics approval number [1] 309613 0
H21REA269

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

Contacts
Principal investigator
Name 114770 0
Ms Lauren Brook
Address 114770 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 114770 0
Australia
Phone 114770 0
+61 493248428
Fax 114770 0
Email 114770 0
[email protected]
Contact person for public queries
Name 114771 0
Lauren Brook
Address 114771 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 114771 0
Australia
Phone 114771 0
+61 492998628
Fax 114771 0
Email 114771 0
[email protected]
Contact person for scientific queries
Name 114772 0
Lauren Brook
Address 114772 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 114772 0
Australia
Phone 114772 0
+61 492998628
Fax 114772 0
Email 114772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data will be available for the results obtained during the clinical trial once all identifying information has been removed.
When will data be available (start and end dates)?
The data will be available immediately after publication with no end date determined.
Available to whom?
Only available for researchers whom provide a sound proposal to requiring the information.
Available for what types of analyses?
For the aims in the approve proposal.
How or where can data be obtained?
Approvals and access come directly from the primary investigator only. Email at [email protected]


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.