Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000152921
Ethics application status
Approved
Date submitted
23/01/2020
Date registered
13/02/2020
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying a biomarker of coffee consumption in urine
Scientific title
Identification of coffee metabolites in the urine of human participants following coffee consumption
Secondary ID [1] 300351 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coffee consumption 315964 0
Condition category
Condition code
Diet and Nutrition 314235 314235 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 314407 314407 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the study day, participants will attend the research facility after an overnight fast and provide a fasted urine sample. Participants will also be asked to avoid coffee/coffee products for 10 hours prior to collection of this fasting urine sample. Following this, participants will be given a coffee to drink (4 g instant coffee in 150 mL hot water) by a dietitian or trained researcher. Participants will then continue collecting their own urine for the next 24 hours, into provided containers. Participants are also asked to consume no more coffee during those 24 hours, but can otherwise eat and drink ad libitum. Participants returned their collected urine the following morning.
Intervention code [1] 316628 0
Treatment: Other
Intervention code [2] 316749 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322622 0
Detection of metabolites of dimethoxycinnamic acid in the urine of participants post-coffee consumption by LCMS analysis
Timepoint [1] 322622 0
24 hour urine sample post-coffee consumption.
Secondary outcome [1] 379087 0
No secondary outcomes
Timepoint [1] 379087 0
Not applicable

Eligibility
Key inclusion criteria
Adults able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Diagnosed medical conditions that affect the gastrointestinal tract or metabolism
• Urinary tract infections or other conditions related to the bladder.
• Any dietary allergies that prevent consuming coffee.

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)
Not applicable - single group study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - single group study.
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
11/12/2019
Date of last data collection
Anticipated
Actual
18/12/2019
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304774 0
University
Name [1] 304774 0
Monash University
Country [1] 304774 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 305090 0
None
Name [1] 305090 0
None
Address [1] 305090 0
None
Country [1] 305090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305189 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305189 0
Ethics committee country [1] 305189 0
Australia
Date submitted for ethics approval [1] 305189 0
Approval date [1] 305189 0
12/11/2019
Ethics approval number [1] 305189 0
Project 21719

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99546 0
Prof Gary Williamson
Address 99546 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 99546 0
Australia
Phone 99546 0
+61 3 99056649
Fax 99546 0
Email 99546 0
[email protected]
Contact person for public queries
Name 99547 0
Gary Williamson
Address 99547 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 99547 0
Australia
Phone 99547 0
+61 3 99056649
Fax 99547 0
Email 99547 0
[email protected]
Contact person for scientific queries
Name 99548 0
Gary Williamson
Address 99548 0
Department of Nutrition, Dietetics and Food, Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 99548 0
Australia
Phone 99548 0
+61 3 99056649
Fax 99548 0
Email 99548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results will be available.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
For the purpose of conducting meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.