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 wellbeing and other health related outcomes including biochemical parameters, and gut symptoms in adults aged 35-60 years with elevated (mild to moderate) stress, anxiety and depression. Gold kiwifruit 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 gut health and functioning. The CSIRO will lead a 10-week trial involving daily delivery of gold kiwifruit in adults experiencing current mild to moderate levels of psychological distress and who present with sub-optimal vitamin C concentrations.
Interventions
Brief name: Daily consumption of gold kiwifruit for 4 weeks
Arm 1: 2-week pre-intervention baseline.
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 complete a 2-week baseline prior to commencing the intervention phase. During the intervention phase participants will co
Brief name: Daily consumption of gold kiwifruit for 4 weeks Arm 1: 2-week pre-intervention baseline. 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 complete a 2-week baseline prior to commencing the intervention phase. During the intervention phase 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
CSIRO
Study design
Allocation
Randomised controlled trial
Intervention model
Other
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 * male or female * non-smoker (i.e. no history of smoking or nicotine replacement therapy within the last six months) * plasma vitamin C >10µmol/L and < 50µmol/L (lower and upper thresholds for suboptimal vitamin C status) * scores in the mild and moderate ranges on a minimum of one of either the depression (10-13 & 14-20), anxiety (8-9 & 10-14) and stress (15-18 & 19-25) subscales of the DASS-21 at screening * willing to provide written informed consent * access to smartphone and willing to download free application from app store * able to access own 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 * scores in the severe or extremely severe ranges on a minimum of two of either the depression (greater than or equal to 21), anxiety (greater than or equal to 15) and stress (greater than or equal to 26) subscales of the DASS-21 at screening * a score in the high range (greater than or equal to 7) on the Habitual Dietary Intake Questionnaire (HDIvC) at screening * 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
Outcome results
None listed