Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000259741
Ethics application status
Approved
Date submitted
8/02/2022
Date registered
14/02/2022
Date last updated
15/02/2023
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Gold Kiwifruit and Psychological Health
Scientific title
Zespri®SunGold Kiwifruit and Psychological Health in adults experiencing mild to moderate symptoms of depression and anxiety.
Secondary ID [1] 306408 0
Nil known
Universal Trial Number (UTN)
U1111-1274-0176
Trial acronym
GoKiPH
Linked study record
ACTRN12621001321831 served as a feasibility trial for the present record and informed design, inclusion and exclusion criteria, methodology and recruitment protocols of the present record.

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 325152 0
Diet and nutrition 325154 0
Gastrointestinal health 325155 0
Condition category
Condition code
Mental Health 322557 322557 0 0
Other mental health disorders
Diet and Nutrition 322558 322558 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 322559 322559 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily consumption of 2 gold kiwifruit per day for 28 consecutive days.
Arm 1: Kiwifruit intervention
Arm 2: Diet as usual

Intervention: Participants will be supplied with kiwifruit to store and consume in their own domicile for the duration of the study. They will be instructed on storage and consumption protocols. Participants will be responsible for delivery of intervention. Participants will consume 2 gold kiwifruit each day for a period of 28 days.
The intervention will occur in the participant’s domicile.
Compliance will be monitored throughout the study. Participants will complete a daily paper log to assess protocol compliance. Compliance logs will be reviewed at each clinic visit. Any queries from the logs will be followed up via a phone call. Participants who consume less than 80% of the required product in a given fortnight will receive a courtesy call from site study staff to problem solve compliance issues. Subjects will be instructed to bring back any remaining product to site for accountability purposes. Compliance will also be assessed against blood biomarkers taken across the intervention.
Intervention code [1] 322782 0
Treatment: Other
Comparator / control treatment
Arm 2: Diet as usual.
Participants will be instructed to consume their typical diet across the 28 day intervention. At the end of the 28-day intervention, participants in both Arm will enter a 14-day phaseout period, before crossing over to the Arm for a further 28 days.
Control group
Active

Outcomes
Primary outcome [1] 330354 0
Mean difference in Profile of Mood States questionnaire short form (POMS-SF) total mood disturbance (TMD) scores between baseline and end-intervention.
Timepoint [1] 330354 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28) (Primary timepoint).
Secondary outcome [1] 405926 0
Changes in subjective vitality as assessed by the mean difference in scores on the Subjective Vitality Scale (SVS) between post-intervention and baseline.
Timepoint [1] 405926 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28).
Secondary outcome [2] 405927 0
Change in psychological wellbeing assessed as mean difference in scores on the Warwick-Edinburgh Mental Well-being Scale (WEBWMS) between post-intervention and baseline.
Timepoint [2] 405927 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28).
Secondary outcome [3] 405928 0
Changes in psychological wellbeing as assessed by mean differences in scores on the Profile of Mood States – Short Form 6 sub-scales between post-intervention and baseline
Timepoint [3] 405928 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28).
Secondary outcome [4] 405929 0
Gut symptoms and intestinal comfort assessed by mean differences in scores on the Gastrointestinal Symptom Rating Scale (GSRS). Gut symptoms and intestinal comfort will be assessed as a composite construct.
Timepoint [4] 405929 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28).
Secondary outcome [5] 405930 0
Mean difference in fasting plasma vitamin C concentrations (µmol/L) between post-intervention and baseline
Timepoint [5] 405930 0
Baseline (day 0), mid-intervention (day 14), end-intervention (day 28).

Eligibility
Key inclusion criteria
• 18-60 years of age inclusive at time of phone screening
• male or female
• scores in the mild (20-24) and moderate (25-29) ranges on the Kessler Psychological Distress Scale at phone screening
• willing to provide written informed consent
• a current email address/service
• fluent in English
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• aversion and/or allergy/intolerance to kiwifruit and/or latex
• needle phobia or fainting due to fear of needles
• consumption of gold kiwifruit within 14 days prior to baseline
• not prepared to abstain from consumption of gold kiwifruit (other than study product) for the duration of the trial
• use of vitamin C or probiotics supplements within 84 days (3 months) of baseline and not prepared to abstain for the study duration
• previous or current diagnosis of Diabetes Mellitus or bleeding disorders (e.g., haemophilia)
• use of prescription medications for the treatment and management of gastrointestinal disorders within 84 days (3 months) of baseline and not prepared to abstain from use for the study duration
• initiation of, or alterations to, a course of anti-depressants, anxiolytic agents or anti-psychotics within last 6 months of baseline
• received an investigational drug within 84 days (3 months) prior to baseline that in the opinion of the Principal Investigator may affect the applicant’s ability to participate in the study of the study’s results
• currently enrolled in any other dietary intervention study
• previously enrolled in dietary intervention studies at CSIRO involving kiwifruit
• current smoker or vaper (i.e. history of smoking, vaping or nicotine replacement therapy within the last six months)

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
.Eligible participants will be allocated to Group condition based on a pre-determined block randomisation algorithm using assigned study identification number at the date of enrolment (Baseline visit).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The necessary sample size for the current study was calculated using GPower. Calculations returned a minimum of n = 60 participants would be required for a repeated-measures model assuming a small within-between interaction effect (chi square = 0.02) with 80% power (alpha = 0.05). Utilising the current crossover design, this number is reduced by 50%, thus requiring a minimum of n = 30 participants for the present study. Assuming a 15% dropout rate, the study will require a sample size of N = 36.
A current version of the SPSS statistical software package (IBM SPSS Statistics 28) will be used to conduct analyses, along with ancillary libraries as needed. For all analyses a Type I error rate of 5% will be assumed. Differences between baseline and end-intervention will be analysed using a repeated-measures model in order to estimate mean treatment effects, with a small within-between interaction effect (chi square = 0.02). . The final analyses will evaluate the relationship between changes in psychological wellbeing and venous blood concentrations across the kiwifruit arm. Changes in the primary and secondary outcome measures will be analysed based on change in mean scores between baseline and end-intervention measurements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2022
Actual
21/06/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
19/12/2022
Date of last data collection
Anticipated
30/01/2023
Actual
19/12/2022
Sample size
Target
36
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 36694 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310706 0
Commercial sector/Industry
Name [1] 310706 0
Zespri International Ltd
Country [1] 310706 0
New Zealand
Funding source category [2] 310707 0
Government body
Name [2] 310707 0
Commonwealth Scientific and Industrial Research Organisation
Country [2] 310707 0
Australia
Funding source category [3] 310708 0
University
Name [3] 310708 0
University of Adelaide
Country [3] 310708 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zespri International Ltd
Address
400 Maunganui Road, Mt Maunganui, 3116, New Zealand
Country
New Zealand
Secondary sponsor category [1] 311925 0
Government body
Name [1] 311925 0
Commonwealth Scientific and Industrial Research Organisation
Address [1] 311925 0
SAHMRI (South Australian Health and Medical Research Institute), North Terrace, Adelaide, South Australia 5000
Country [1] 311925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310288 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 310288 0
Ethics committee country [1] 310288 0
Australia
Date submitted for ethics approval [1] 310288 0
08/02/2022
Approval date [1] 310288 0
11/05/2022
Ethics approval number [1] 310288 0

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

Contacts
Principal investigator
Name 117134 0
Dr Ian Zajac
Address 117134 0
Nutrition and Health Program, Health & Biosecurity, CSIRO
SAHMRI (South Australian Health and Medical Research Institute), North Terrace, Adelaide, South Australia 5000
Country 117134 0
Australia
Phone 117134 0
+61 8 8303 8875
Fax 117134 0
Email 117134 0
[email protected]
Contact person for public queries
Name 117135 0
Ian Zajac
Address 117135 0
Nutrition and Health Program, Health & Biosecurity, CSIRO
SAHMRI (South Australian Health and Medical Research Institute), North Terrace, Adelaide, South Australia 5000
Country 117135 0
Australia
Phone 117135 0
+61 8 8303 8875
Fax 117135 0
Email 117135 0
[email protected]
Contact person for scientific queries
Name 117136 0
Ian Zajac
Address 117136 0
Nutrition and Health Program, Health & Biosecurity, CSIRO
SAHMRI (South Australian Health and Medical Research Institute), North Terrace, Adelaide, South Australia 5000
Country 117136 0
Australia
Phone 117136 0
+61 8 8303 8875
Fax 117136 0
Email 117136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participant confidentiality and security of data. Any IPD collected during the trial must conform with the Privacy Act 1988 (Cth) and in accordance with this Act and the NHMRC National Statement on Ethical Conduct in Human Research (2007) as amended from time to time.


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.