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Trial registered on ANZCTR


Registration number
ACTRN12621000302853
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
18/03/2021
Date last updated
18/03/2021
Date data sharing statement initially provided
18/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The bioavailability of anthocyanin after consuming a single dose of red kiwifruit and their effects on innate immunity in healthy individuals.
Scientific title
Investigating the bioavailability of anthocyanins and their metabolites and the effects of these compounds on the immune system after consuming a single serve of red kiwifruit in healthy individuals.
Secondary ID [1] 303230 0
None
Universal Trial Number (UTN)
U1111-1263-9567
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrient absorption 320381 0
Innate immunity 320382 0
Condition category
Condition code
Metabolic and Endocrine 318283 318283 0 0
Normal metabolism and endocrine development and function
Inflammatory and Immune System 318284 318284 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-arm repeated measures study that will allow us to evaluate the bioavailability of red kiwifruit anthocyanins (and their metabolites) following the consumption of a single serve of red kiwifruit. Additionally, we seek to determine whether the bioavailability of red kiwifruit corresponds with changes in immune response following stimulation with known immune activators. Prospective participants who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s principal investigator. During this session, the study’s principal investigator (research scientist, PhD) will explain the purpose of the study and what is expected from them as a participant. They give potential participants a copy of the information sheet and health questionnaire for them to take home and complete.

Recruited participants will be required to complete a trial day where they will be required to consume the red kiwifruit intervention. Participants will be instructed to refrain from consuming a list of food, drinks and dietary supplements containing anthocyanins 24 hours before their trial day. On their trail day, participants will be given a standardised breakfast bar (694 calories; 16.7 g protein, 23.3 g total fat, 89.3 total carbohydrate and 10 g dietary fibre) to consume with water to have for breakfast 2 hours before the beginning of the trial. At the beginning of the trial, participants will be given 200 g of blended red kiwifruit to consume. This dose of kiwifruit is equivalent to a standard serve of two red kiwifruit. Venous blood samples (approximately 5 mL) will be collected from participants at 0, 1, 2, 4 and 6 hours after consuming their treatment. The trial coordinator (research associate) of this study will be instructing all participants of what is required of them on their trial day.

To monitor participants’ adherence to the dietary restrictions, each participant will be asked to recall if they have consumed any foods containing anthocyanins from a list provided within the last 24 hours prior to starting their trial day. A baseline blood sample will also be collected on each trial day before participants are given their intervention. This will be analysed for anthocyanin and other polyphenolics and will indicate participants’ adherence to the dietary restrictions.
Intervention code [1] 319535 0
Treatment: Other
Comparator / control treatment
No control group.

Although there is no control group in this study, the change in bioavailable anthocyanins post dietary intervention will be compared with each participant's baseline results. Similarly, each participant's immune response post consumption of their dietary intervention will be compared with their baseline results.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326267 0
The concentration of anthocyanins (and their metabolites) will be measured in blood plasma samples collected from all participants at the same timepoints on all trial days.
Timepoint [1] 326267 0
This will be measured from blood samples collected at 0, 1, 2, 4 and 6 hours after treatment consumption during each trial day using validated in-house high performance liquid chromatography (HPLC) methods.
Secondary outcome [1] 390825 0
Blood glucose levels
Timepoint [1] 390825 0
Blood glucose levels will be measured from an aliquot of venous blood samples collected at 0, 1, 2, 4 and 6 hours after treatment consumption. Glucose will be measured using "point-of-test" biosensors.
Secondary outcome [2] 390827 0
Composite biomarkers of inflammatory cytokine production by monocytic THP-1 cells - media concentration of IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNF-a, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-gamma, IL-12p70, CXCL8 (IL-8), TGF-ß1
Timepoint [2] 390827 0
These biomarkers of inflammation will be collected from conditioned media of THP-1 monocytes exposed to plasma collected at 0, 2 and 4 hours after kiwifruit ingestion and stimulated with lipopolysaccharide, a known immune activator. These parameters will be assayed using a bead-based multiplex panel and measured by flow cytometry.
Secondary outcome [3] 390829 0
Composite biomarkers of inflammatory cytokine production by peripheral blood mononuclear cells (PBMC) - media concentration of IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNF-a, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-gamma, IL-12p70, CXCL8 (IL-8), TGF-ß1
Timepoint [3] 390829 0
These biomarkers of inflammation will be collected from conditioned media of PBMC isolated from venous blood collected at 0, 2 and 4 hours after kiwifruit ingestion and stimulated with phorbol myristate acetate (PMA)/ionomycin, a known immune activator. These parameters will be assayed using a bead-based multiplex panel and measured by flow cytometry.

Eligibility
Key inclusion criteria
Healthy individuals (male or female) 18 – 55 years who are able to provide written consent to participate in this study will be selected from this study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling to unable to provide written consent or comply with the study procedures. Participants will also be excluded if they have known hypersensitivity or intolerance to kiwifruit or kiwifruit derived products. In addition, participants will be excluded if they are pregnant, planning to get pregnant in the immediate future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) recent bacterial or viral illness or (iii) are taking medication that affects the properties of blood (e.g. blood clotting).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Data will be expressed as mean +/- standard error. ANOVA analysis of anthocyanin bioavailability data will be conducted to determine time interaction of anthocyanin (and metabolite) bioavailability and immune response of THP-1 and PBMC following stimulation with LPS and PMA/ionomycin, respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/03/2021
Actual
Date of last participant enrolment
Anticipated
16/04/2021
Actual
Date of last data collection
Anticipated
28/05/2021
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 23395 0
New Zealand
State/province [1] 23395 0
Manawatu

Funding & Sponsors
Funding source category [1] 307637 0
Government body
Name [1] 307637 0
The New Zealand Institute for Plant & Food Research Ltd.
Country [1] 307637 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Dominic Lomiwes
Address
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road,
Fitzherbert,
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 308323 0
None
Name [1] 308323 0
Address [1] 308323 0
Country [1] 308323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307679 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 307679 0
Ethics committee country [1] 307679 0
New Zealand
Date submitted for ethics approval [1] 307679 0
19/02/2021
Approval date [1] 307679 0
10/03/2021
Ethics approval number [1] 307679 0

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

Contacts
Principal investigator
Name 108110 0
Dr Dominic Lomiwes
Address 108110 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 108110 0
New Zealand
Phone 108110 0
+64 6 355 6113
Fax 108110 0
Email 108110 0
[email protected]
Contact person for public queries
Name 108111 0
Pramod Gopal
Address 108111 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 108111 0
New Zealand
Phone 108111 0
+64 6 953 7678
Fax 108111 0
Email 108111 0
[email protected]
Contact person for scientific queries
Name 108112 0
Dominic Lomiwes
Address 108112 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 108112 0
New Zealand
Phone 108112 0
+64 6 355 6113
Fax 108112 0
Email 108112 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
Ethics requirements for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study.. Furthermore, has potential commercial outcomes and publicly disclosing participant data will jeopardise the company's ability to protect the intellectual property generated from this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10302Ethical approval    Ethics approval from the New Zealand HDEC (Souther... [More Details] 381263-(Uploaded-18-03-2021-09-53-42)-Study-related document.pdf



Results publications and other study-related documents

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