Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000755831
Ethics application status
Approved
Date submitted
12/05/2021
Date registered
16/06/2021
Date last updated
20/09/2022
Date data sharing statement initially provided
16/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of vitamin C from kiwifruit on human immune cell function
Scientific title
The effect of vitamin C from kiwifruit on human immune cell cytokine responses in young adults aged 18 - 35 years.
Secondary ID [1] 303545 0
Nil known
Universal Trial Number (UTN)
U1111-1265-3453
Trial acronym
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Vitamin C nutritional status 321906 0
Immune health 321907 0
Condition category
Condition code
Inflammatory and Immune System 319634 319634 0 0
Normal development and function of the immune system
Diet and Nutrition 319635 319635 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a randomised human intervention study to determine the effect of dietary supplementation with 2 SunGold kiwifruit per day or placebo tablet on the function of mononuclear immune cells (monocytes and lymphocytes). We will screen prospective participants for low plasma vitamin C status (likely due to low daily fruit and vegetable intake) and will randomly allocate the enrolled participants to either a daily kiwifruit intervention or a placebo tablet. The period of the intervention is 4 weeks.

Adherence to the assigned condition will be monitored by laboratory testing of blood plasma vitamin C status at baseline, mid-point at end of the intervention period, and by quantifying fruit/tablet return.
Intervention code [1] 320549 0
Treatment: Other
Comparator / control treatment
This is a parallel arms study with an intervention group (two Sungold kiwifruit per day) or a control (fruit-flavoured placebo chewable tablet).
Control group
Placebo

Outcomes
Primary outcome [1] 327497 0
Cytokine release by peripheral blood mononuclear cells in response to inflammatory challenge, before and after intervention..
Timepoint [1] 327497 0
At baseline and four weeks post-intervention.
Primary outcome [2] 327810 0
Vitamin C levels in peripheral blood mononuclear cells
Timepoint [2] 327810 0
At baseline, at trial midpoint (2 weeks post-intervention) and 4 weeks post intervention.
Primary outcome [3] 327811 0
Plasma vitamin C status
Timepoint [3] 327811 0
At baseline, at midpoint (2 weeks post-interventions) and at 4 weeks post intervention.
Secondary outcome [1] 395409 0
Determination of changes in gene expression in a subset of peripheral blood mononuclear cell samples following kiwifruit intake.
Timepoint [1] 395409 0
At baseline and 4 weeks post-intervention
Secondary outcome [2] 396677 0
Effect of kiwifruit intervention on susceptibility to respiratory illness, monitored by symptom survey.
Timepoint [2] 396677 0
Up to 12 weeks beyond the end of intervention period.

Eligibility
Key inclusion criteria
Inclusion criteria (all required): Males or females 18-65 years; Plasma vitamin C levels <40 µmol/L at baseline.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (one required); Taking prescription medication (within past three months); Allergy/intolerance to kiwifruit; Daily smoker: Taking vitamin C supplements (within past three months); High fruit/juice & vegetable consumption (5 or more servings/day); Excessive alcohol consumption (more than 21 standard drinks/week); Diabetes mellitus; Bleeding disorders; Fear of needles.

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)
Central randomisation by computer-generated sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using 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

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparative analysis of pre- and post-intervention samples.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2021
Actual
16/06/2021
Date of last participant enrolment
Anticipated
30/07/2021
Actual
12/11/2021
Date of last data collection
Anticipated
22/10/2021
Actual
17/12/2021
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 23703 0
New Zealand
State/province [1] 23703 0
Canterbury

Funding & Sponsors
Funding source category [1] 307969 0
University
Name [1] 307969 0
University of Otago, Christchurch
Country [1] 307969 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345, Christchurch 8140,
Country
New Zealand
Secondary sponsor category [1] 308685 0
University
Name [1] 308685 0
University of Otago, Dunedin
Address [1] 308685 0
PO Box 56, Dunedin 9054
Country [1] 308685 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307963 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 307963 0
Ethics committee country [1] 307963 0
New Zealand
Date submitted for ethics approval [1] 307963 0
Approval date [1] 307963 0
10/05/2021
Ethics approval number [1] 307963 0
21/CEN/104

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

Contacts
Principal investigator
Name 109062 0
Prof Margreet Vissers
Address 109062 0
Department of Pathology and Biomedical Science, University of Otago, Christchurch PO Box 4345, Christchurch, 8140.
Country 109062 0
New Zealand
Phone 109062 0
+64 3 364 1524
Fax 109062 0
Email 109062 0
[email protected]
Contact person for public queries
Name 109063 0
Margreet Vissers
Address 109063 0
Department of Pathology and Biomedical Science, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140.
Country 109063 0
New Zealand
Phone 109063 0
+64 3 364 1524
Fax 109063 0
Email 109063 0
[email protected]
Contact person for scientific queries
Name 109064 0
Margreet Vissers
Address 109064 0
Department of Pathology and Biomedical Science, University of Otago, Christchurch PO Box 4345, Christchurch 8140.
Country 109064 0
New Zealand
Phone 109064 0
+64 3 364 1524
Fax 109064 0
Email 109064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified results data.
When will data be available (start and end dates)?
From three months and up to five years after publication of results.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Analyses that further the aims of the study, and meta-analyses, with permission from the PI.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, together with a requirement to sign a data access agreement. Contact details for PI: Prof Margreet Vissers, Email: [email protected]


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.