Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000494336
Ethics application status
Approved
Date submitted
7/08/2008
Date registered
30/09/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the effects of kiwifruit products on in vitro immune cell responses from healthy volunteers
Scientific title
In healthy volunteers, does in vitro incubation of blood-derived immune cells with kiwifruit products have an effect on immune function?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immune cell responses to in vitro incubation with kiwifruit products 3520 0
Condition category
Condition code
Inflammatory and Immune System 3674 3674 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will provide three blood samples of 50 mL each. The first two blood samples from each subject will be used for baseline measurement of immune cell markers, including markers of innate and acquired immune responses.

The third blood sample will be incubated with a ZESPRI Gold kiwifruit puree for two hours, after which time immune cell markers will be measured as for the baseline samples. The puree will be added to cells at final dilutions of 1:64, 1:128, 1:256, and 1:512.
Intervention code [1] 3237 0
Not applicable
Comparator / control treatment
Immune cell responses within each participant will be compared between baseline blood samples and the sample incubated with kiwifruit products.
Control group
Dose comparison

Outcomes
Primary outcome [1] 4580 0
Changes in blood markers of immune cell function (innate and acquired immune responses, including assays for phagocytosis, neutrophil oxidative burst, natural killer cell activity, T-cell activation, and cytokine production) in response to in vitro incubation with kiwifruit products.
Timepoint [1] 4580 0
Immediately following in vitro incubation of immune cells with kiwifruit products
Secondary outcome [1] 7740 0
None
Timepoint [1] 7740 0
None

Eligibility
Key inclusion criteria
Healthy persons of any gender who have been vaccinated against tetanus within the past year
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or trying to become pregnant, recent viral illnesses, chronic illnesses affecting the immune system, high/low blood pressure, blood disorders, or taking medication for blood disorders e.g. anticoagulants.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 1102 0
New Zealand
State/province [1] 1102 0
Auckland

Funding & Sponsors
Funding source category [1] 3701 0
Commercial sector/Industry
Name [1] 3701 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Country [1] 3701 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Address
Private Bag 92169, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3319 0
Commercial sector/Industry
Name [1] 3319 0
Zespri International Limited
Address [1] 3319 0
PO Box 4043, Mount Maunganui South
400 Maunganui Road, Mount Maunganui
Country [1] 3319 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5752 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5752 0
Ministry of Health, PO Box 1031, Hamilton
Ethics committee country [1] 5752 0
New Zealand
Date submitted for ethics approval [1] 5752 0
Approval date [1] 5752 0
20/11/2006
Ethics approval number [1] 5752 0
NTY/06/09/082

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

Contacts
Principal investigator
Name 28818 0
Address 28818 0
Country 28818 0
Phone 28818 0
Fax 28818 0
Email 28818 0
Contact person for public queries
Name 11975 0
Dr Margot Skinner
Address 11975 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 92169
Auckland 1142
Country 11975 0
New Zealand
Phone 11975 0
+64 9 9257126
Fax 11975 0
+64 9 9257001
Email 11975 0
[email protected]
Contact person for scientific queries
Name 2903 0
Dr Margot Skinner
Address 2903 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Private Bag 92169
Auckland 1142
Country 2903 0
New Zealand
Phone 2903 0
+64 9 9257126
Fax 2903 0
+64 9 9257001
Email 2903 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
No additional documents have been identified.