Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000830291
Ethics application status
Approved
Date submitted
14/05/2018
Date registered
16/05/2018
Date last updated
20/10/2021
Date data sharing statement initially provided
20/10/2021
Date results information initially provided
20/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute dose-response variation in human absorption and metabolism of anthocyanins from ‘Lapins’ cherries - a randomised, cross-over pilot study.
Scientific title
Acute dose-response variation in human absorption and metabolism of anthocyanins from ‘Lapins’ cherries - a randomised, cross-over pilot study.
Secondary ID [1] 294878 0
None
Secondary ID [2] 294879 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biomarker of anthocyanin-intake 307831 0
Condition category
Condition code
Diet and Nutrition 306876 306876 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 306890 306890 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sweet ‘Lapins’ cherries were harvested in January 2018, washed, de-stemmed, pitted, vacuum-packed in portions of 200 g or 500 g and stored at -20 °C to minimise anthocyanin degradation. The cherries are first-grade fruit, that were picked from a commercial orchid.

a) the dose administered in each treatment:
arm 1: 500g cherries, arm 2: 200g cherries

b) the frequency/duration of administration
Participant will consume cherries once off in each arm

c) the mode of administration
Cherries will be eaten whole, with a standardised breakfast low in flavonoids (wheat biscuits, milk)

d) the duration of 'washout' between the crossed-over treatments
There will be a two-week washout between intervention arms

e) any strategies used to monitor adherence to the intervention
The research team will use direct observation to monitor adherence to the intervention
Intervention code [1] 301192 0
Lifestyle
Comparator / control treatment
No control group.

Determining dose-dependent differences in dose (against baseline measures)
Control group
Active

Outcomes
Primary outcome [1] 305868 0
Quantification of intact anthocyanins in urine
Timepoint [1] 305868 0
At baseline and after cherry consumption (0h), urine samples will be collected over 24 h (time-points 1, 3, 6 h, and pooled sample between 6 and 12 h and between 12 and 24 h)
Primary outcome [2] 305886 0
Quantification of anthocyanin-related metabolites (vanillic acid, hippuric acid, ferulic acid) in urine
Timepoint [2] 305886 0
At baseline and after cherry consumption (0h), urine samples will be collected over 24 h (time-points 1, 3, 6 h, and pooled sample between 6 and 12 h and between 12 and 24 h)
Secondary outcome [1] 346852 0
Quantification of intact anthocyanins in faecal matter
Timepoint [1] 346852 0
Baseline (the day prior) and all stool samples within 24h following cherry consumption
Secondary outcome [2] 346889 0
Quantification of anthocyanin-related metabolites (vanillic acid, hippuric acid, ferulic acid) in faecal matter
Timepoint [2] 346889 0
Baseline (the day prior) and all stool samples within 24h following cherry consumption

Eligibility
Key inclusion criteria
Eligible participants (healthy adults, male/female, aged 18y+) are those who do not have allergies to anthocyanin-containing fruit and vegetables (including sweet cherry) or standardised, low-flavonoid food provided on the study days, those who do not have diseases of the gastrointestinal tract (e.g. Crohn’s disease – which may affect metabolism of food), and those who do not take flavonoid-containing dietary supplements (as this may confound the metabolites).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include allergies to specified foods, diseases of the gastrointestinal tract, consumption of flavonoid-containing dietary supplements, pregnancy and/or breastfeeding (as this may affect metabolism), and an inability to provide informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by a computer-generated block randomization by an researcher independent to the data collection
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2018
Actual
1/04/2019
Date of last participant enrolment
Anticipated
30/10/2018
Actual
1/06/2019
Date of last data collection
Anticipated
31/10/2018
Actual
1/07/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 299464 0
University
Name [1] 299464 0
University of Tasmania
Country [1] 299464 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Better Health Theme Directors
17 Liverpool St (Private Bag 23)
Hobart TAS 7000 Australia
Country
Australia
Secondary sponsor category [1] 298763 0
None
Name [1] 298763 0
none
Address [1] 298763 0
none
Country [1] 298763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300371 0
University of Tasmania Health and Medical HREC
Ethics committee address [1] 300371 0
Office of Research Services, University of Tasmania, Private Bag 1, Hobart, TAS, 7001
Ethics committee country [1] 300371 0
Australia
Date submitted for ethics approval [1] 300371 0
21/05/2018
Approval date [1] 300371 0
12/11/2018
Ethics approval number [1] 300371 0
H0017363

Summary
Brief summary
This randomised, within subject cross-over pilot study aims to quantify the acute dose-dependent changes in intact anthocyanins (such as cyanidin-3-rutinoside, cyanidin-3-glucoside, peonidin-3-rutinoside and pelargonin-3-rutinoside) and phenolic acid metabolites (such as vanillic acid, hippuric acid, ferulic acid) in biological specimens (urine, faecal matter) over 24 hours after consumption of 200 g and 500 g anthocyanin-rich Tasmanian sweet cherries (‘Lapins’).
It is hypothesised that anthocyanin-rich Tasmanian sweet cherry consumption will increase anthocyanin and phenolic acid metabolite biomarkers in biological samples (urine, faecal matter) in a dose-dependent manner.
This is a preliminary and fundamental step which will be useful in future studies, as a measure of compliance to the intervention, and may provide evidence of the mechanisms of action by which cherry anthocyanins are perceived to work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83438 0
Dr Katherine Kent
Address 83438 0
Katherine Kent
Centre for Rural Health, University of Tasmania
Locked Bag 1322
Launceston Tasmania
7250
Country 83438 0
Australia
Phone 83438 0
+61363244053
Fax 83438 0
Email 83438 0
[email protected]
Contact person for public queries
Name 83439 0
Dr Katherine Kent
Address 83439 0
Katherine Kent
Centre for Rural Health, University of Tasmania
Locked Bag 1322
Launceston Tasmania
7250
Country 83439 0
Australia
Phone 83439 0
+61363244053
Fax 83439 0
Email 83439 0
[email protected]
Contact person for scientific queries
Name 83440 0
Dr Katherine Kent
Address 83440 0
Katherine Kent
Centre for Rural Health, University of Tasmania
Locked Bag 1322
Launceston Tasmania
7250
Country 83440 0
Australia
Phone 83440 0
+61363244053
Fax 83440 0
Email 83440 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


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.