Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000030673
Ethics application status
Approved
Date submitted
6/01/2023
Date registered
12/01/2023
Date last updated
12/01/2023
Date data sharing statement initially provided
12/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a single dose of anthocyanins on exercise-induced bronchoconstriction
Scientific title
Effect of single dose anthocyanins on lung hyper-responsiveness in adults aged 18 to 55 suffering from exercise-induced bronchoconstriction
Secondary ID [1] 308700 0
Nil Known
Universal Trial Number (UTN)
U1111-1286-7458
Trial acronym
ANEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced bronchoconstriction 328632 0
Asthma 328633 0
Condition category
Condition code
Respiratory 325636 325636 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 325637 325637 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be ten 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 1050 mg anthocyanin taken 60 minutes before testing. 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 mylar bags for each dose. The 7-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 intervention will be administered under supervision in the laboratory during testing.
Intervention code [1] 325164 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] 333483 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] 333483 0
60 minutes from consumption to testing of effectiveness of the intervention. 7 days washout period applied.
Secondary outcome [1] 417228 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] 417228 0
Blood inflammatory markers will be assessed at baseline, 75min and 90 min post consumption of intervention for both visits.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Aged between 18 and 55 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
55 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
The people administering 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
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/01/2023
Date of last participant enrolment
Anticipated
2/06/2023
Actual
Date of last data collection
Anticipated
16/06/2023
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39218 0
4305 - Ipswich
Recruitment postcode(s) [2] 39219 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 312926 0
University
Name [1] 312926 0
University of Southern Queensland
Country [1] 312926 0
Australia
Primary sponsor type
Individual
Name
Lauren Taylah
Address
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country
Australia
Secondary sponsor category [1] 314608 0
Individual
Name [1] 314608 0
Dean Mills
Address [1] 314608 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country [1] 314608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312198 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [1] 312198 0
Ethics committee country [1] 312198 0
Australia
Date submitted for ethics approval [1] 312198 0
17/10/2022
Approval date [1] 312198 0
30/11/2022
Ethics approval number [1] 312198 0
H22REA246

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

Contacts
Principal investigator
Name 123822 0
Ms Lauren Taylah
Address 123822 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 123822 0
Australia
Phone 123822 0
+61 493248428
Fax 123822 0
Email 123822 0
[email protected]
Contact person for public queries
Name 123823 0
Lauren Taylah
Address 123823 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 123823 0
Australia
Phone 123823 0
+61 492998628
Fax 123823 0
Email 123823 0
[email protected]
Contact person for scientific queries
Name 123824 0
Lauren Taylah
Address 123824 0
University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305
Country 123824 0
Australia
Phone 123824 0
+61 492998628
Fax 123824 0
Email 123824 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.