ANZCTR - Registration

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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]

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

Asthma

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Alternative and Complementary Medicine

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]

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]

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]

60 minutes from consumption to testing of effectiveness of the intervention. 7 days washout period applied.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4305 - Ipswich

Recruitment postcode(s) [2]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Southern Queensland

Address [1]

11 Salisbury Drive, Ipswich, QLD, 4305

Country [1]

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]

Individual

Name [1]

Dean Mills

Address [1]

University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Southern Queensland Human Research Ethics Committee

Ethics committee address [1]

11 Salisbury Drive, Ipswich, QLD, 4301

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/10/2022

Approval date [1]

30/11/2022

Ethics approval number [1]

H22REA246

Summary

Brief summary

Asthma is an inflammatory disease of the airways that affects over 7% of the world’s population (Papi et al., 2018). Exercise-induced bronchoconstriction (EIB) is a type of asthma which is defined as a transient narrowing of the airways in response to exercise and affects 90% of asthma sufferers and up to 15% of non-asthmatic individuals (Bonini & Usmani, 2018). Asthma and EIB can be managed either by rapid bronchodilatation to relieve respiratory symptoms or long-term suppression of inflammation. However, frequent use of reliever medicines can lead to the user becoming tolerant to the treatment and long-term control medicines have several undesirable side effects. Dietary and supplement interventions have been reported to reduce the effects of asthma and EIB (Williams et al., 2016). These may represent a cost-saving, effective and safe method for reducing the incidence of asthmatic attacks. Anthocyanins are coloured pigments that are responsible for the colours red, purple and blue in fruits and vegetables. Current animal studies have found that after consumption of anthocyanins, inflammation was reduced, and lung function was improved (Park et al., 2007). Whether anthocyanins could improve respiratory symptoms and lung function in otherwise healthy humans with EIB is unknown. This will be the first study to determine the role anthocyanins have on lung function and inflammation in individuals with EIB.
It is hypothesised the anthocyanin supplementation with increase lung function following eucapnic voluntary hyperpnoea.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Lauren Taylah

Address

University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305

Country

Australia

Phone

+61 493248428

Fax

lauren.taylah@usq.edu.au

Contact person for public queries

Name

Lauren Taylah

Address

University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305

Country

Australia

Phone

+61 492998628

Fax

lauren.taylah@usq.edu.au

Contact person for scientific queries

Name

Lauren Taylah

Address

University of Southern Queensland. 11 Salisbury Drive, Ipswich, QLD, 4305

Country

Australia

Phone

+61 492998628

Fax

lauren.taylah@usq.edu.au

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 Lauren.taylah@usq.edu.au

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.

Trial Review

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