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Trial registered on ANZCTR


Registration number
ACTRN12613000451707
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
19/04/2013
Date last updated
2/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of berryfruit extract on airways inflammation and airways obstruction in asthma
Scientific title
A cross-over, double-blind, randomised controlled, proof of concept trial of berryfruit extract versus placebo on the FeNO level of 28 steroid naive subjects with diagnosed asthma and an FeNO of >40ppb.
Secondary ID [1] 282154 0
BA01
Universal Trial Number (UTN)
U1111-1138-3264
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 288660 0
Condition category
Condition code
Respiratory 289004 289004 0 0
Asthma
Alternative and Complementary Medicine 289276 289276 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Encapsulated Berryfruit extract (1000mg), once daily, by mouth, for 28 days. Subjects will go through a washout period of 28 days between each intervention period of the study.
Study extract/ placebo compliance will be captured via a capsule count, performed at the end of each intervention period (at visits 2 and 4) - study product will be collected and counted by study staff and a compliance log completed for accountability purposes.
Intervention code [1] 286763 0
Lifestyle
Comparator / control treatment
Encapsulated matched Placebo (containing cellulose), once daily, by mouth, for 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 289120 0
Fractional exhaled Nitric Oxide (FeNO) level
FeNO will be measured as per the ATS guidelines (2005), via either chemoluminescence using an online nitric oxide monitor (NIOX; Aerocrine AB, Solna, Sweden), or a NIOX MINO device.
Timepoint [1] 289120 0
Measured at Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [1] 301858 0
Spirometry (FEV1)
FEV1 measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.
Timepoint [1] 301858 0
Measured at baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [2] 301859 0
Resistance/Conductance (sRaw / sGaw)
sRAW/ sGAW measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.
Timepoint [2] 301859 0
Measured at baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [3] 301860 0
Small airways function (MMEF 25-75)
MMEF 25-75 measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.
Timepoint [3] 301860 0
Measured at baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [4] 301861 0
Peripheral blood eosinophil count
Timepoint [4] 301861 0
Measured at baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [5] 302716 0
Shortened Asthma Control Questionnaire (ACQ-5)
Timepoint [5] 302716 0
Measured at Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [6] 303276 0
Reliever use (captured from question 6 of ACQ)
Timepoint [6] 303276 0
Measured at baseline, 4 weeks, 8 weeks, 12 weeks

Eligibility
Key inclusion criteria
Doctor diagnosis of asthma
Steroid naive (no inhaled or oral corticosteroid in the last 90 days)
Exhaled FeNO of >40ppb
Aged 18-75
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Unable or unwilling to comply with study procedures, including not consuming confounding foodstuffs during study periods
Known hypersensitivity to berryfruit polyphenolic compounds Known pregnancy
Any other safety concern at the investigator’s discretion

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)
Numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biostatistician will conduct simple randomisation using a randomisation table created by computer software (i.e. 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 assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be by a mixed linear model to account for the cross-over design with a random effect for participant and baseline FENO as a co-variate. The FENO will be logarithm transformed for analysis purposes as our past experience is that this variable has a highly skewed distribution. Exponentiation of the difference in logarithm FENO can be interpreted as the ratio of mean FENO between two randomised groups.
A sample size of 24 has 80% power, alpha 5%, to detect a difference in logarithm FeNO of 0.227, equivalent to a ratio of mean values of 1.25; based on paired SD for the difference in logarithm FeNO at two visits in a group of steroid naive asthmatics taking a placebo.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2013
Actual
26/06/2013
Date of last participant enrolment
Anticipated
1/07/2013
Actual
3/09/2013
Date of last data collection
Anticipated
Actual
4/12/2013
Sample size
Target
28
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 4947 0
New Zealand
State/province [1] 4947 0
Wellington

Funding & Sponsors
Funding source category [1] 286924 0
Charities/Societies/Foundations
Name [1] 286924 0
Malaghan Institute of Medical Research
Country [1] 286924 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute for Plant & Food Research Ltd
Address
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 285712 0
None
Name [1] 285712 0
Address [1] 285712 0
Country [1] 285712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288981 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 288981 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 288981 0
New Zealand
Date submitted for ethics approval [1] 288981 0
18/03/2013
Approval date [1] 288981 0
09/04/2013
Ethics approval number [1] 288981 0
13/CEN/47

Summary
Brief summary
This study is being done to find out whether a New Zealand berryfruit extract is able to reduce markers of airway inflammation in people with asthma. The aim is to provide scientific evidence to support the berryfruit extract as a functional food, able to assist with human health.
Trial website
Trial related presentations / publications
Power S, Williams M, Semprini A, Munro C, Caswell-Smith R, Pilcher J, Holliday M, Fingleton J, Harper J, Hurst R, Weatherall M. RCT of the effect of berryfruit polyphenolic cultivar extract in mild steroid-naive asthma: a cross-over, placebo-controlled study. BMJ open. 2017 Mar 1;7(3):e013850.

DOI: http://dx.doi.org/10.1136/bmjopen-2016-013850
Public notes

Contacts
Principal investigator
Name 38630 0
Dr Sharon Power
Address 38630 0
Medical Research Institute
Level 7 CSB Building
Wellington Hospital
Riddiford Street
Wellington 6021
Country 38630 0
New Zealand
Phone 38630 0
+64 4 805 0147
Fax 38630 0
Email 38630 0
[email protected]
Contact person for public queries
Name 38631 0
Sharon Power
Address 38631 0
Medical Research Institute
Level 7 CSB Building
Wellington Hospital
Riddiford Street
Wellington 6021
Country 38631 0
New Zealand
Phone 38631 0
+64 4 805 0235
Fax 38631 0
Email 38631 0
[email protected]
Contact person for scientific queries
Name 38632 0
Sharon Power
Address 38632 0
Medical Research Institute
Level 7 CSB Building
Wellington Hospital
Riddiford Street
Wellington 6021
Country 38632 0
New Zealand
Phone 38632 0
+64 4 805 0235
Fax 38632 0
Email 38632 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseRCT of the effect of berryfruit polyphenolic cultivar extract in mild steroid-naive asthma: A cross-over, placebo-controlled study.2017https://dx.doi.org/10.1136/bmjopen-2016-013850
N.B. These documents automatically identified may not have been verified by the study sponsor.