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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
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

Study type
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

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

Key inclusion criteria
Adults able to provide informed consent.

Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 304774 0
Name [1] 304774 0
Monash University
Address [1] 304774 0
Wellington Rd, Clayton VIC 3800
Country [1] 304774 0
Primary sponsor type
Monash University
Wellington Rd, Clayton VIC 3800
Secondary sponsor category [1] 305090 0
Name [1] 305090 0
Address [1] 305090 0
Country [1] 305090 0

Ethics approval
Ethics application status
Ethics committee name [1] 305189 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305189 0
Wellington Rd, Clayton VIC 3800
Ethics committee country [1] 305189 0
Date submitted for ethics approval [1] 305189 0
Approval date [1] 305189 0
Ethics approval number [1] 305189 0
Project 21719

Brief summary
Antioxidants are naturally-occurring compounds found in plant-derived foods and beverages, such as coffee. The antioxidants we are going to focus on in this study are the chlorogenic acids. These are a family of strong antioxidants present in coffee that may show some health benefits. The amount of chlorogenic acid intake in a typical diet is high and, for people who drink it, coffee is the major dietary source of these antioxidants. Coffee contains high levels of chlorogenic acids which consist of phenolic acids including caffeic acid, ferulic acid and dimethoxycinnamic acid. Dimethoxycinnamic acid (DMCA) is found at high levels in coffee, and is very well absorbed. It is found in the bloodstream just a few minutes after drinking. However, the final form in urine is a mystery. Since DMCA is only found in significant amounts in coffee, then if we could find the chemical form in urine, it could be a useful biomarker of coffee intake in populations. Knowing the chemical form would also allow us to define its pathway of metabolism.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 (
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary