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Trial registered on ANZCTR
Registration number
ACTRN12617001031358
Ethics application status
Approved
Date submitted
12/07/2017
Date registered
17/07/2017
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
KiwiC for Vitality Study: Effect of kiwifruit on Vitality, Fatigue and Wellbeing
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Scientific title
Kiwifruit and Vitality: a randomised controlled trial on the effect of kiwifruit on vitality, fatigue and wellbeing in participants with low vitamin C status
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Secondary ID [1]
292388
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None
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Universal Trial Number (UTN)
U1111-1196-8929
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vitality
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Fatigue
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Wellbeing
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Condition category
Condition code
Mental Health
303307
303307
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1, Two SunGold kiwifruit per day for 4 weeks during the intervention period. The intervention period is preceded by a 2 week lead-in and followed by a 2 week washout where no intervention is given.
Arm 2, One oral tablet containing 250 mg vitamin C per day for 4 weeks during the intervention period. The intervention period is preceded by a 2 week lead-in and followed by a 2 week washout where no intervention is given.
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Intervention code [1]
298562
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Treatment: Other
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Intervention code [2]
298598
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Treatment: Drugs
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Comparator / control treatment
Arm 3, One oral placebo tablet containing 0 mg vitamin C per day for 4 weeks during the intervention period. The intervention period is preceded by a 2 week lead-in and followed by a 2 week washout where no intervention is given.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Total mood disturbance score assessed using the Profile of Mood States (POMS) questionnaire.
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Assessment method [1]
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Timepoint [1]
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Fortnightly for 8 weeks; intermittent nightly smartphone surveys for 8 weeks
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Primary outcome [2]
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Total fatigue score assessed using the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF).
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Assessment method [2]
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Timepoint [2]
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Fortnightly for 8 weeks.
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Primary outcome [3]
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Positive psychological wellbeing assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
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Assessment method [3]
302713
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Timepoint [3]
302713
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Fortnightly for 8 weeks.
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Secondary outcome [1]
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Plasma vitamin C.
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Assessment method [1]
336787
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Timepoint [1]
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Fortnightly for 8 weeks.
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Secondary outcome [2]
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Fatigue-energy scale of the Short Form Health Survey (SF-36)
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Assessment method [2]
336788
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Timepoint [2]
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Intermittent nightly smartphone surveys for 10 weeks.
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Secondary outcome [3]
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Positive psychological wellbeing assessed using the short Flourishing Scale
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Assessment method [3]
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Timepoint [3]
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Intermittent nightly smartphone surveys for 8 weeks.
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Eligibility
Key inclusion criteria
Plasma vitamin C levels <45 µmol/L
Non-smoker
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Taking prescription medication (within past three months)
Allergy/intolerance to Kiwifruit
Recent smoker (within previous year)
Taking vitamin C supplements (within past three months)
High fruit/juice & vegetable consumption (greater than or equal to 5 servings/day)
Excessive alcohol consumption ( greater than 21 standard drinks/week)
Diabetes mellitus
Bleeding disorders
Fainting due to fear of needles
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved with use of sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers generation and allocation by sealed opaque envelopes
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size was calculated based on previously attained data using the POMS questionnaire. With a power of 80%, alpha of 0.05 and effect size of 0.8, it was calculated that 25 participants per group were required. Recruitment of 40 participants per group accounts for the observation of potentially smaller effect sizes for some wellbeing measures. An additional 10% (5 participants per group) will be recruited to allow for withdrawal over the duration of the study, therefore requiring 135 participants.
Statistical differences between and within groups for the fortnightly measurements will be determined using ANOVA with post-hoc analysis. Multivariate modelling will also be carried out to take into account time and confounders. Statistical trends over time between and within groups for the smartphone measurements will be analysed using growth curve modelling using the Hierarchical Linear Modelling programme. Statistical significance will be set at P=0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/07/2017
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Actual
4/09/2017
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Date of last participant enrolment
Anticipated
13/04/2018
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Actual
19/04/2018
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Date of last data collection
Anticipated
22/06/2018
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Actual
14/06/2018
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Sample size
Target
135
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Accrual to date
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Final
155
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Recruitment outside Australia
Country [1]
9042
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New Zealand
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State/province [1]
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Dunedin and Christchurch
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Zespri International
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Address [1]
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400 Maunganui Road
Mt Maugnganui 3149
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago, Christchurch
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Address
2 Riccarton Avenue
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
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University
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Name [1]
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University of Otago, Dunedin
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Address [1]
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362 Leith Street
Dunedin 9016
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Commettee
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Ethics committee address [1]
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Ministry of Health 133 Molesworth Street Thornton Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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30/05/2017
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Approval date [1]
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28/06/2017
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Ethics approval number [1]
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17/NTB/104
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Summary
Brief summary
The purpose of the study is to assess the effect of adding SunGold kiwifruit to the diet on changes in vitality, fatigue, and wellbeing. The study aims to determine whether any improvements in these outcomes can be attributed to the high vitamin C content of the fruit. In a previous pilot study, we observed that intake of two kiwifruit/day for six weeks provided a significant 31% increase in vigour and a significant 38% decrease in fatigue in young men with a higher than average total mood disturbance score as assessed by the Profile of Mood States (POMS) questionnaire. Interestingly, intake of half a kiwifruit/day did not have any effect on mood scores, suggesting a dose dependency. We are now proposing a larger study that includes both men and women, has more extensive measures of vitality, fatigue and wellbeing, and includes a vitamin C and a placebo comparison arm. This randomised controlled trial brings together the expertise of Professor Margreet Vissers, Dr Anitra Carr and Dr Tamlin Conner, New Zealand's leading research experts in vitamin C bioavailability and function (Vissers and Carr) and psychological wellbeing (Conner). We will recruit participants who have low vitamin C status. Individuals will be randomised to one of three interventions: (1) Two SunGold kiwifruit per day; (2) vitamin C tablet daily (equivalent to the vitamin C content of two kiwifruit); (3) placebo tablet daily. We will monitor vitality/fatigue/wellbeing, using intermittent nightly smartphone surveys and traditional fortnightly assessments. The study will last for 8 weeks (2 week lead-in; 4 week intervention; 2 week washout period). Our hypothesis is that consumption of two SunGold kiwifruit per day will improve vitality, decrease fatigue, and improve wellbeing.
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Trial website
http://web.psy.otago.ac.nz/kiwifruit
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Margreet Vissers
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Address
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Center for Free Radical Research
Department of Pathology
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8140
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Country
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New Zealand
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Phone
76142
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+64 3 364 1524
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Fax
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+64 3 364 1083
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Email
76142
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[email protected]
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Contact person for public queries
Name
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Tamlin Conner
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Address
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Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
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Country
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New Zealand
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Phone
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+64 3 479 7624
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Margreet Vissers
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Address
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Center for Free Radical Research
Department of Pathology
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8140
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Country
76144
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New Zealand
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Phone
76144
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+64 3 364 1524
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Fax
76144
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+64 3 364 1083
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Email
76144
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified results data.
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following all results publication.
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Available to whom?
Researchers, on a case-by-case basis at the discretion of Primary Sponsor.
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Available for what types of analyses?
Only to further the aims of the present study and for meta-analyses.
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How or where can data be obtained?
Access subject to approvals by Principal Investigator, together with requirement to sign data access agreement.
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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
Source
Title
Year of Publication
DOI
Embase
Could a kiwifruit a day keep the doctor away?.
2020
https://dx.doi.org/10.1016/S2468-1253%2820%2930163-1
Embase
Kiwic for vitality: Results of a randomized placebo-controlled trial testing the effects of kiwifruit or vitamin c tablets on vitality in adults with low vitamin c levels.
2020
https://dx.doi.org/10.3390/nu12092898
Embase
Initial evidence of variation by ethnicity in the relationship between vitamin c status and mental states in young adults.
2021
https://dx.doi.org/10.3390/nu13030792
N.B. These documents automatically identified may not have been verified by the study sponsor.
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