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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

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1196-8929

Trial acronym

Linked study record

Health condition

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

Vitality

Fatigue

Wellbeing

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Drugs

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.

Control group

Placebo

Outcomes

Primary outcome [1]

Total mood disturbance score assessed using the Profile of Mood States (POMS) questionnaire.

Timepoint [1]

Fortnightly for 8 weeks; intermittent nightly smartphone surveys for 8 weeks

Primary outcome [2]

Total fatigue score assessed using the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF).

Timepoint [2]

Fortnightly for 8 weeks.

Primary outcome [3]

Positive psychological wellbeing assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)

Timepoint [3]

Fortnightly for 8 weeks.

Secondary outcome [1]

Plasma vitamin C.

Timepoint [1]

Fortnightly for 8 weeks.

Secondary outcome [2]

Fatigue-energy scale of the Short Form Health Survey (SF-36)

Timepoint [2]

Intermittent nightly smartphone surveys for 10 weeks.

Secondary outcome [3]

Positive psychological wellbeing assessed using the short Flourishing Scale

Timepoint [3]

Intermittent nightly smartphone surveys for 8 weeks.

Eligibility

Key inclusion criteria

Plasma vitamin C levels <45 µmol/L
Non-smoker

Minimum age

18 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

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

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)

Allocation concealment will be achieved with use of sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random numbers generation and allocation by sealed opaque envelopes

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

17/07/2017

Actual

4/09/2017

Date of last participant enrolment

Anticipated

13/04/2018

Actual

19/04/2018

Date of last data collection

Anticipated

22/06/2018

Actual

14/06/2018

Sample size

Target

135

Accrual to date

Final

155

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Dunedin and Christchurch

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Zespri International

Address [1]

400 Maunganui Road Mt Maugnganui 3149

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago, Christchurch

Address

2 Riccarton Avenue
Christchurch 8140

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Otago, Dunedin

Address [1]

362 Leith Street Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Commettee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
Thornton
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/05/2017

Approval date [1]

28/06/2017

Ethics approval number [1]

17/NTB/104

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.

Trial website

http://web.psy.otago.ac.nz/kiwifruit

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Margreet Vissers

Address

Center for Free Radical Research Department of Pathology University of Otago, Christchurch 2 Riccarton Avenue Christchurch 8140

Country

New Zealand

Phone

+64 3 364 1524

Fax

+64 3 364 1083

[email protected]

Contact person for public queries

Name

Tamlin Conner

Address

Department of Psychology University of Otago PO Box 56 Dunedin 9054

Country

New Zealand

Phone

+64 3 479 7624

Fax

[email protected]

Contact person for scientific queries

Name

Margreet Vissers

Address

Center for Free Radical Research Department of Pathology University of Otago, Christchurch 2 Riccarton Avenue Christchurch 8140

Country

New Zealand

Phone

+64 3 364 1524

Fax

+64 3 364 1083

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers, on a case-by-case basis at the discretion of Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified results data.

What types of analyses could be done with individual participant data?

• Only to further the aims of the present study and for meta-analyses.

When can requests for individual participant data be made (start and end dates)?

From:
Beginning 3 months and ending 5 years following all results publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator, together with requirement to sign data access agreement.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically