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A human pilot study to investigate the effect of daily consumption of gold kiwifruit for 2 weeks on transcriptomic changes in buccal epithelial cells and blood in healthy males.

A pilot human study to investigate the effect of gold kiwifruit consumption on transcriptomic changes in buccal epithelial swabs in healthy males: A novel platform to establish the bio-efficacy and appropriate health applications of kiwifruit

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001359921
Enrollment
6
Registered
2020-12-17
Start date
2021-01-15
Completion date
2021-01-29
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Proper nutrition plays a significant role in helping to lead a healthy lifestyle. There is increasing interest in how fruit bioactive compounds improve health. Gold kiwifruit has been identified as having beneficial health effects, however the full health implications are not fully understood. Successfully establishing transcriptomic analysis of buccal epithelial cells and bacterial cells from mouth swabs, with the possible comparison to RNA from blood samples, allows for a non-invasive method to predict health outcomes. Importantly, this new approach will provide an insight into how diet changes affect health as measured through gene expression changes. Results from this study will allow us to identify novel effects of kiwifruit along with a mechanistic explanation of known kiwifruit effects on health. In this study, we aim to examine the effect of kiwifruit intake on transcriptomic changes in buccal epithelium and bacteria, as a novel, non-invasive platform to establish the bio-efficacy and appropriate health application of gold kiwifruit.

Interventions

This is a prospective intervention study that will allow us to examine the effectiveness of gold kiwifruit consumption on modulating buccal epithelial gene expression, associated with health outcomes. Prospective participants who have passed the study's inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s trial coordinator. During this session, the trial coordinator will introduce them to the subjective scales and questionnaires tha

This is a prospective intervention study that will allow us to examine the effectiveness of gold kiwifruit consumption on modulating buccal epithelial gene expression, associated with health outcomes. Prospective participants who have passed the study's inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s trial coordinator. During this session, the trial coordinator will introduce them to the subjective scales and questionnaires that they will be asked to respond to during the trial days. On the first trial day, participants will arrive in the morning in a fasted state (12 hrs) and supply oral epithelial swabs, saliva (3 ml) and venous blood samples (~ 9 ml) for RNA extraction from fasted participants (12 hrs) who are advised to not brush their teeth or drink water in the 2 hrs preceding sampling, RNAseq analysis, cDNA synthesis and gene expression analysis. Blood RNA extractions will be taken as a backup in the case that buccal epithelial RNA is of low quality. In addition, Profile of Mood States (PoMS) rating scale, and skin colourimetry measures will be taken. All participants will then be given a 2 week supply of Gold Kiwifruit (3 kiwifruit per day to be consumed) by the trial coordinator. It is expected that the duration of the trial visit will be 2 hours. The trial coordinator will verify with each participant daily, the number of kiwifruit they have consumed via messaging. Following the 14 day feeding intervention, all recruited participants will be required to return to complete final measures (trial day 15). Each participant will be subjected to the same measures as on day 1. Participants will arrive in the morning in a fasted state (12 hrs) and supply oral epithelial swabs, saliva (3 ml) and venous blood samples (~ 9 ml) for RNA extraction from fasted participants (12 hrs) who are advised to not brush their teeth or drink water in the 2 hrs preceding sampling, RNAseq analysis, cDNA synthesis and gene expression analysis. Blood RNA extractions will be taken as a backup in the case that buccal epithelial RNA is of low quality. In addition, Profile of Mood States (PoMS) rating scale, and skin colourimetry measures will be taken. It is expected that the duration of the trial visit will be 2 hours.

Sponsors

Plant & Food Research
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy individuals (male) 18-60 years, who are not following any specialised diets and can complete the dietary requirements of the trial will be selected (determined in familiarisation session). Participants will be required to complete a health questionnaire and provide written consent for this study.

Exclusion criteria

Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with study procedures. All participants will be in good cardiovascular and oral health and did not report any use of antibacterial mouthwash or antibiotics for at least 6 months prior to study commencement. They were free from non-prescription medication including those known to interfere with stomach acid production. Participants will also be excluded if they have (i) known hypersensitivity or intolerance to kiwifruit, In addition, participants will be excluded if they have any of the following conditions: blood borne diseases (e.g., hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness, (iv) are taking any medication that affects the properties of blood (e.g. blood clotting) (iv) oral health conditions (e.g., recent dental work, tooth decay & periodontal diseases).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026