None listed
Conditions
Brief summary
The aim of this study is to investigate the effects of daily consumption of gold kiwifruit on psychological health and other health related outcomes including biochemical parameters, and gut symptoms in adults aged 18-60 years with symptoms of anxiety and depression. Gold kiwifruits contain exceptionally high levels of vitamin C. vitamin C is recognised for its important role in mood, cognition and physical health and wellbeing. Gold kiwifruit has the potential to infer beneficial effects on the constructs of psychological wellbeing and aspects of physical health. The CSIRO will lead a 10-week randomised crossover trial involving daily delivery of gold kiwifruit in adults experiencing current psychological distress.
Interventions
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 partic
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.
Sponsors
Zespri International Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
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)
Outcome results
None listed