Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000774820
Ethics application status
Approved
Date submitted
12/04/2021
Date registered
21/06/2021
Date last updated
28/10/2022
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of BerriQi® Boysenberry and apple product on lung function following ozone exposure
Scientific title
Investigating the effect of BerriQi® Boysenberry and apple product consumption on lung function and immune protection following acute ozone exposure induced lung inflammation in healthy volunteers.
Secondary ID [1] 303892 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
reduced lung function 321472 0
lung inflammation 321473 0
Condition category
Condition code
Respiratory 319232 319232 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 319233 319233 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BerriQi® Boysenberry and apple powder capsules –1000mg. The capsules are commercially prepared from freeeze dried and milled Boysenberry and apple. The capsules will be formulated to contain a known amount of total anthocyanins so thatparticipants can consume a total of 1400mg total anthocyanins in one or two capsules.
The capsules will be consumed daily for 5 days prior to the ozone exposure, on the day of the ozone exposure 1 hour before ozone exposure and then for 2 days following the ozone exposure. To monitor adherence, participants will be given one week's worth of capsules for the first week and asked to return the unconsumed capsules.

All participants will undergo a 2 week washout prior to starting the study, the dietary intervention duration is 8 days with ozone or control exposure on day 6 followed by another 2 week washout period and 8 days of the same dietary intervention with ozone or control exposure on day 6 (opposite of what they were previously exposed to) before the participants cross-over onto the other dietary intervention.

All participants will be exposed to ozone at a set concentration within a controlled environment for 2 hours to induce acute lung inflammation. the exact concentration will be determined in a pilot study. All participants will also be exposed to plain air within a controlled environment for 2 hours as a control.
Intervention code [1] 320199 0
Lifestyle
Comparator / control treatment
The base of the placebo is commercially prepared dextrose powder with natural colours and flavours added. The placebo contains no bioactives and will be provided as the same size capsules as the active intervention.
The appearance and taste of the placebo is identical to the intervention
All participants will be exposed to ozone at a set concentration within a controlled environment for 2 hours to induce acute lung inflammation. the exact concentration will be determined in a pilot study. All participants will also be exposed to plain air within a controlled environment for 2 hours as a control.
Control group
Placebo

Outcomes
Primary outcome [1] 327102 0
Exhaled nitric oxide (FeNO) will be measured using an exhaled nitric oxide detector that participants breath into to measure nitric oxide in their breath. Nitric oxide is a gas produced by cells involved in inflammation and an increase of 10% (10ppb) from baseline is considered to be a clinically relevant indicator of lung inflammation.
Timepoint [1] 327102 0
Baseline, immediately post (0h) and 2 (primary timepoint), 24h and 48h post ozone exposure
Primary outcome [2] 327103 0
Forced expiratory volume in 1 minute (FEV1) and forced vital capacity (FVC) will be measured using a clinical spirometer to assess these clinically relevant parameters of participant’s lung function.
Timepoint [2] 327103 0
Baseline, immediately post (0h) and 2 (primary timepoint),, 24h and 48h post ozone exposure
Secondary outcome [1] 393790 0
Plasma cytokine concentrations (IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNF-a, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-g, IL-12p70, CXCL8 (IL-8), TGF-ß1) will be assayed using a bead-based multiplex panel (LEGENDplex™ Human Essential Immune Response Panel (13-plex)) and measured using flow cytometry.
Timepoint [1] 393790 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [2] 393878 0
White blood cells from venous blood samples will stained with fluorophore-conjugated antibodies to identify granulocytes, monocytes and lymphocytes by flow cytometry.
Timepoint [2] 393878 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [3] 393879 0
plasma samples will be used to determine oxidative potential (OPA)
Timepoint [3] 393879 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [4] 393880 0
Bioavailability: plasma concentrations of anthocyanins,
Timepoint [4] 393880 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [5] 393881 0
RNA isolation from whole blood to measure Aryl-hydrocarbon receptor (AhR) expression to identify potential mechanism of action of BerriQi® boysenberry and apple beverage
Timepoint [5] 393881 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [6] 393882 0
Subjective lung health will be assessed by asking participants to respond to lung health symptom scores (VAS)
Timepoint [6] 393882 0
Baseline, immediately post (0h) and 2, 24h 48h and one week post ozone exposure
Secondary outcome [7] 395998 0
plasma samples will be used to determine malondialdehyde (MDA) concentration
Timepoint [7] 395998 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [8] 395999 0
plasma samples will be used to determine protein carbonyls concentration
Timepoint [8] 395999 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [9] 396000 0
identification of bioactives: untargeted metabolomics analysis of blood plasma samples
Timepoint [9] 396000 0
Baseline, immediately post (0h) and 2, 24h and 48h post ozone exposure
Secondary outcome [10] 396001 0
Subjective lung health questionnaire will be assessed by asking participants to complete the Chronic Respiratory Questionnaire
Timepoint [10] 396001 0
Baseline, immediately post (0h) and 2h, 24h 48h and one week post ozone exposure

Eligibility
Key inclusion criteria
Healthy male and female (50/50) non-pregnant individuals 18-40 years of age with normal lung function at baseline will be selected
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• If they are unwilling or unable to provide informed written consent or comply with the study procedures.
• If they have known hypersensitivity or intolerance to Boysenberry or apple-derived products and/or specific food additives.
• If they have a diagnosed health conditions that impair their lung function (asthma, COPD, fibrosis), diabetes or cardiovascular disease.
• If they smoke.
If they have a job where they have high occupational exposure to respiratory irritants such as ozone or particulate matter (eg welder)
In addition, participants will also be excluded if they have the following health conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting)

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)
Allocation is not concealed, participants will take part in both arms of the study
Methods used to generate the sequence in which subjects will be randomised (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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis of these studies also indicate that a group size of n=70-80 participants is needed to detect the difference between ozone challenge which causes this degree of respiratory function change and an intervention treatment which gives partial protection against effect (two sample, one sided t-test, with 80% power). Assuming a similar magnitude of (treatment) effect in this proposed study, we intend to recruit 80 participants for the intervention study. However, we will be informed by the data obtained during the pilot study to ensure that the intervention study is sufficiently powered.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
27/10/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 23587 0
New Zealand
State/province [1] 23587 0
Palmerston North

Funding & Sponsors
Funding source category [1] 308283 0
Government body
Name [1] 308283 0
High Value Nutrition National Science Challenge
Country [1] 308283 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute for Plant and Food Research
Address
Private Bag 11600,
Palmerston North 4442,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309085 0
University
Name [1] 309085 0
Massey University
Address [1] 309085 0
School of Sport Exercise Nutrition Massey University Private Bag 11-222 Palmerston North 4442 New Zealand
Country [1] 309085 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308257 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308257 0
Ethics committee country [1] 308257 0
New Zealand
Date submitted for ethics approval [1] 308257 0
16/10/2021
Approval date [1] 308257 0
14/07/2022
Ethics approval number [1] 308257 0

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

Contacts
Principal investigator
Name 110102 0
Dr Odette Shaw
Address 110102 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 110102 0
New Zealand
Phone 110102 0
+64 06 355 6163
Fax 110102 0
Email 110102 0
[email protected]
Contact person for public queries
Name 110103 0
Dominic Lomiwes
Address 110103 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 110103 0
New Zealand
Phone 110103 0
+64 06 3556113
Fax 110103 0
Email 110103 0
[email protected]
Contact person for scientific queries
Name 110104 0
Odette Shaw
Address 110104 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 110104 0
New Zealand
Phone 110104 0
+64 06 355 6163
Fax 110104 0
Email 110104 0
[email protected]

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
17503Ethical approval    381761-(Uploaded-21-10-2022-10-44-11)-Study-related document.pdf



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.