Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000398505p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BerriQi for Kids: Boysenberry and apple product for respiratory recovery in kids
Scientific title
BerriQi (Boysenberry and apple product) for post-respiratory infection recovery in primary school-age children in Motueka, NZ
Secondary ID [1] 311633 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory 333074 0
Upper respiratory tract infection 333333 0
Condition category
Condition code
Respiratory 329763 329763 0 0
Other respiratory disorders / diseases
Infection 330021 330021 0 0
Other infectious diseases
Alternative and Complementary Medicine 330022 330022 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BerriQi is a freeze-dried powder from Boysenberry and apple. Custom chewable tablets are made each containing 500 mg of BerriQi per chewable tablet. Additional ingredients include 500 mg xylitol and 25 mg of magnesium stearate.
Each participant will be instructed to consume 2 chewable tablets ( 1000 mg BerriQi) daily for 2 weeks. Participants will self-report on the daily questionnaire if they took BerriQi that day, which will be used as an indicator of adherence.
Intervention code [1] 328093 0
Treatment: Other
Comparator / control treatment
The placebo product will be a BerriQi chewable tablets in which the Boysenberry component has been heat treated to remove anthocyanin activity, but the apple component remains the same as the active product.
The nutritional value remains the same between the active IP and placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 337542 0
To assess if ingestion of two BerriQi chewable tablets (500 mg each) for 14 days compared to placebo can improve quality of life as determined by global illness severity domain from WURSS-K questionnaires
Timepoint [1] 337542 0
Baseline (the first day of school in which a child is absent due to respiratory symptoms, prior to beginning BerriQi treatment), Day 7 (7 days after the first school absence due to respiratory illness; primary outcome). Day 14 (14 days after the first school absence due to respiratory illness).
Secondary outcome [1] 432263 0
Severity of respiratory infection symptoms will be assessed as a composite.
Timepoint [1] 432263 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [2] 432264 0
Assess the duration (number of days) until the average composite symptom score decreases by at least one point.
Timepoint [2] 432264 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [3] 433297 0
Assess the duration (number of days) until the severity of runny nose symptoms scores decrease by at least one point.
Timepoint [3] 433297 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [4] 433298 0
Assess the duration (number of days) until the severity of stuffy nose symptoms scores decrease by at least one point.
Timepoint [4] 433298 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [5] 433299 0
Assess the duration (number of days) until the severity of sneezing symptom scores decrease by at least one point.
Timepoint [5] 433299 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [6] 433300 0
Assess the duration (number of days) until the severity of sore throat symptom scores decrease by at least one point.
Timepoint [6] 433300 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [7] 433301 0
Assess the duration (number of days) until the severity of cough symptom scores decrease by at least one point.
Timepoint [7] 433301 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [8] 433302 0
Assess the duration (number of days) until the severity of feeling tired symptom scores decrease by at least one point.
Timepoint [8] 433302 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [9] 433303 0
Assess the severity of runny nose symptoms.
Timepoint [9] 433303 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [10] 433304 0
Assess the severity of stuffy nose symptoms.
Timepoint [10] 433304 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [11] 433305 0
Assess the severity of sneezing symptoms.
Timepoint [11] 433305 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [12] 433306 0
Assess the severity of sore throat symptoms.
Timepoint [12] 433306 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [13] 433307 0
Assess the severity of cough symptoms.
Timepoint [13] 433307 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [14] 433308 0
Assess the severity of feeling tired symptoms.
Timepoint [14] 433308 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [15] 433309 0
Severity of respiratory infection functional impacts will be assessed as a composite.
Timepoint [15] 433309 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.
Secondary outcome [16] 433310 0
Assess the duration (number of days) until the average composite functional impact score decreases by at least one point.
Timepoint [16] 433310 0
Baseline (first day of school absence, pre-intervention) versus each day of the intervention period up to 14 days.

Eligibility
Key inclusion criteria
Participants and their family are willing and able to give informed consent for participation in the trial.
5-13 years of age.
Willing to comply with the study protocol .
Have upper respiratory infection symptoms triggering a school absence.
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergic to berries
Not willing to provide informed consent

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be completed by an independent biostatistician from the University of Auckland.
Power analysis of this study indicates that we will require at least 52 participants to detect changes in global severity item (“How sick do you feel today”),
With an expected 20% attrition, we will need at least 62 participants in total, in a 2 arm parallel design study type I error a=0.05, power of 80% .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 26180 0
New Zealand
State/province [1] 26180 0

Funding & Sponsors
Funding source category [1] 315956 0
Commercial sector/Industry
Name [1] 315956 0
Anagenix Ltd
Country [1] 315956 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Anagenix
Address
Country
New Zealand
Secondary sponsor category [1] 318097 0
None
Name [1] 318097 0
Address [1] 318097 0
Country [1] 318097 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314783 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314783 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 314783 0
New Zealand
Date submitted for ethics approval [1] 314783 0
28/03/2024
Approval date [1] 314783 0
Ethics approval number [1] 314783 0

Summary
Brief summary
Seasonal upper respiratory tract infections are nearly unavoidable, contributing to school absenteeism, employee absenteeism, and reduced quality of life. To our knowledge, all-natural, child-appropriate, non-pharmaceutical, scientifically supported symptom relief is rare. Therefore, this study aims to assess if BerriQi - a natural whole fruit-based product from Boysenberry and apple supports immune and lung health in primary school-age kids with respiratory infections.
Validated illness-specific quality of life questionnaire (WURSS-K) will be used to assess the severity and duration of respiratory symptoms for 14 days in children missing school due to upper respiratory tract infection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132714 0
Dr Starin Mckeen
Address 132714 0
Anagenix Ltd., Level 1, 272 Parnell Road, Parnell, Auckland 1052
Country 132714 0
New Zealand
Phone 132714 0
+64272569074
Fax 132714 0
Email 132714 0
starin.mckeen@anagenix.com
Contact person for public queries
Name 132715 0
Aahana Shrestha
Address 132715 0
Anagenix Ltd., Level 1, 272 Parnell Road, Parnell, Auckland 1052
Country 132715 0
New Zealand
Phone 132715 0
+64221837265
Fax 132715 0
Email 132715 0
ahanashr@gmail.com
Contact person for scientific queries
Name 132716 0
Aahana Shrestha
Address 132716 0
Anagenix Ltd., Level 1, 272 Parnell Road, Parnell, Auckland 1052
Country 132716 0
New Zealand
Phone 132716 0
+64221837265
Fax 132716 0
Email 132716 0
aahana.shrestha@anagenix.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect individual participants privacy individual's data will not be made available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21770Study protocol  aahana.shrestha@anagenix.com The study protocol is confidential and will not be... [More Details]
21771Informed consent form    Currently, awaiting approval by the Health and Dis... [More Details]
21772Ethical approval    Currently, awaiting approval by the Health and Dis... [More Details]



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.