Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001359921
Ethics application status
Approved
Date submitted
8/10/2020
Date registered
17/12/2020
Date last updated
17/12/2020
Date data sharing statement initially provided
17/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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
Secondary ID [1] 302422 0
None
Universal Trial Number (UTN)
U1111-1258-8219
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 319222 0
Oral Health 319223 0
Condition category
Condition code
Inflammatory and Immune System 317185 317185 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 317712 317712 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318702 0
Lifestyle
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325279 0
A comparison of transcriptomic changes in human oral buccal epithelium and blood following a 2 week kiwifruit feeding intervention in adult males.
Timepoint [1] 325279 0
2 samples to be collected from each participant on day 1 (pre-intervention) & day 15 (end of intervention).
Secondary outcome [1] 387378 0
A comparison of Profile of Mood States (PoMS) rating scale changes following a 2 week kiwifruit feeding intervention in adult males.
Timepoint [1] 387378 0
2 samples to be collected from each participant on day 1 (pre-intervention) & day 15 (end of intervention).
Secondary outcome [2] 387379 0
A comparison of skin colourimetry changes following a 2 week kiwifruit feeding intervention in adult males will be quantified using a handheld spectrophotometer.
Timepoint [2] 387379 0
2 samples to be collected from each participant on day 1 (pre-intervention) & day 15 (end of intervention).
Secondary outcome [3] 387662 0
A comparison of oral microbiome genomic changes following a 2 week kiwifruit feeding intervention in adult males will be performed by extraction and sequencing of bacterial genomic DNA and subsequent bioinformatic analysis.
Timepoint [3] 387662 0
2 samples to be collected from each participant on day 1 (pre-intervention) & day 15 (end of intervention).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory pilot study on 6 males which will generate the data to be used in power analysis for future studies.
Statistical significance for the comparison between two time points will be assessed using a paired Student’s t-test. Where appropriate, the original data will be transformed to achieve normality and constant variance in the residuals. Statistical significance for all indices will be set at P < 0.05 with a confidence level of 95%.

Interactions between the consumption of a kiwifruit and transcriptomic health: Because this is the first study of this kind, this is an exploratory analysis and the effect sizes associated with kiwifruit consumption are unknown. Therefore we will attempt a number of exploratory analyses using Bayesian methods or Deseq analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2021
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
12/02/2021
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 23031 0
New Zealand
State/province [1] 23031 0
Manawatu

Funding & Sponsors
Funding source category [1] 306841 0
Government body
Name [1] 306841 0
Plant & Food Research
Country [1] 306841 0
New Zealand
Primary sponsor type
Government body
Name
Plant & Food Research
Address
Private Bag 11600
Palmerston North
Manawatu
New Zealand
4442
Country
New Zealand
Secondary sponsor category [1] 307413 0
None
Name [1] 307413 0
Address [1] 307413 0
Country [1] 307413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307002 0
Health and Disability Ethics Committees
Ethics committee address [1] 307002 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 307002 0
New Zealand
Date submitted for ethics approval [1] 307002 0
02/10/2020
Approval date [1] 307002 0
09/11/2020
Ethics approval number [1] 307002 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105710 0
Dr Andrew Carroll
Address 105710 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 105710 0
New Zealand
Phone 105710 0
+64 2102660637
Fax 105710 0
Email 105710 0
[email protected]
Contact person for public queries
Name 105711 0
Dr Greg Sawyer
Address 105711 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 105711 0
New Zealand
Phone 105711 0
+64 63556152
Fax 105711 0
Email 105711 0
[email protected]
Contact person for scientific queries
Name 105712 0
Dr Greg Sawyer
Address 105712 0
The New Zealand Institute for Plant and Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 105712 0
New Zealand
Phone 105712 0
+64 63556152
Fax 105712 0
Email 105712 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
Ethics requirements for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study.. Furthermore, this work is industry funded and publicly disclosing participant data will violate our confidentiality agreement to protect the intellectual property generated from this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9323Ethical approval    Proof of official ethics approval to conduct the h... [More Details] 380663-(Uploaded-18-11-2020-12-59-45)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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