ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1263-9567

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nutrient absorption

Innate immunity

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Inflammatory and Immune System

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]

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]

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]

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]

Blood glucose levels

Timepoint [1]

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]

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]

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]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Manawatu

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The New Zealand Institute for Plant & Food Research Ltd.

Address [1]

The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road,
Fitzherbert,
Palmerston North 4474

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/02/2021

Approval date [1]

10/03/2021

Ethics approval number [1]

Summary

Brief summary

Red kiwifruit, which was recently commercialised in New Zealand, has a distinctive red flesh that stems from anthocyanin compounds that are not found in green and gold kiwifruit varieties.   Importantly, there is an abundance of research demonstrating the benefits of anthocyanins on health outcomes including supporting cognition, immunity, exercise recovery and cardiovascular function.  Thus, there is potential to explore the potential health benefits of red kiwifruit that is differentiated from commercial green and gold varieties.

Analysis of red kiwifruit cultivars have reported variable anthocyanin content and composition between cultivars.  Of the anthocyanins that have been identified, cyanidin 3-xylogalactoside was reported to be the most abundant followed by cyanidin 3-galactoside and cyanidin 3-glucoside, highlighting the unique anthocyanin composition compared to other fruits.  Although high cyanidin glycoside-containing foods are associated with improved cognitive performance and immune support, the benefits of consuming red kiwifruit on these outcomes have not yet been explored.

Human clinical studies have demonstrated that health benefits derived from consuming anthocyanin-rich foods is dependent upon the food’s anthocyanin composition and their bioavailability (i.e. their absorption and delivery to the appropriate tissue) of these compounds and their metabolites to exert their effects.  The vascular effects of berryfruit, for example, has been linked to the appearance of specific parent anthocyanins and their metabolites in blood plasma.  Therefore, the health-related outcomes associated with anthocyanins is underpinned by the bioavailability of anthocyanins and their metabolites after consumption.

The bioavailability of red kiwifruit anthocyanins after consumption is yet to be determined.  In this study, we aim to characterise the bioavailability of red kiwifruit anthocyanins and their metabolites in human plasma following the consumption of a single serve (200 g) of red kiwifruit.  In addition, we also aim to investigate whether the bioavailability of red kiwifruit anthocyanins and their (transient) metabolites corresponds with modulation in the immune response following a challenge with known immune activators in vitro.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dominic Lomiwes

Address

The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442

Country

New Zealand

Phone

+64 6 355 6113

Fax

dominic.lomiwes@plantandfood.co.nz

Contact person for public queries

Name

Pramod Gopal

Address

The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442

Country

New Zealand

Phone

+64 6 953 7678

Fax

pramod.gopal@plantandfood.co.nz

Contact person for scientific queries

Name

Dominic Lomiwes

Address

The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442

Country

New Zealand

Phone

+64 6 355 6113

Fax

dominic.lomiwes@plantandfood.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
10302	Ethical 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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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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