Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001210864
Ethics application status
Approved
Date submitted
28/07/2021
Date registered
10/09/2021
Date last updated
10/09/2021
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Coffee for non-alcoholic fatty liver disease
Scientific title
Effect of coffee consumption on hepatic steatosis in non-alcoholic fatty liver disease: a randomised controlled trial
Secondary ID [1] 304857 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease (NAFLD) 322956 0
Condition category
Condition code
Oral and Gastrointestinal 320531 320531 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the coffee group will be required to consume 2-3 coffees per day. Coffee pods and a coffee machine will be supplied for the duration of the trial of 6 months.
1 coffee serve is equal to 1 coffee pod prepared to the participant's preference using supplied coffee machine. Coffees can be consumed at any time during the day.
Participants may consume 2 or 3 coffees per day at their own discretion.
Participants will be required to monitor intake by recording their intake in a coffee diary.

Standard lifestyle modification advice for NAFLD will be given at baseline. Advice based on European Association for the Study of the Liver (EASL) guidelines for NAFLD management.
Intervention code [1] 321243 0
Treatment: Other
Comparator / control treatment
Non-coffee group - no coffee consumption. Standard lifestyle modification advice for NAFLD will be given at baseline.
Control group
Active

Outcomes
Primary outcome [1] 328353 0
Percentage change in hepatic steatosis as quantified by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Timepoint [1] 328353 0
Baseline and 26 weeks after enrolment
Secondary outcome [1] 398697 0
Change in weight measured in kilograms by digital scales
Timepoint [1] 398697 0
Baseline and 26 weeks after enrolment
Secondary outcome [2] 398698 0
Change in Body Mass Index (BMI) as calculated from weight (kg) divided by the square of height in metres. Weight determined using digital scales and height determined by stadiometer
Timepoint [2] 398698 0
Baseline and 26 weeks after enrolment
Secondary outcome [3] 398699 0
Change in waist circumference using tape measure
Timepoint [3] 398699 0
Baseline and 26 weeks after enrolment
Secondary outcome [4] 398700 0
Change in serum alanine transaminase (ALT) as measured from blood serum analysis
Timepoint [4] 398700 0
Baseline and 26 weeks after enrolment
Secondary outcome [5] 398701 0
Change in serum aspartate transaminase (AST) as measured from blood serum analysis
Timepoint [5] 398701 0
Baseline and 26 weeks after enrolment
Secondary outcome [6] 398949 0
Change in serum gamma-glutamyl transferase (GGT) as measured from blood serum analysis
Timepoint [6] 398949 0
Baseline and 26 weeks after enrolment
Secondary outcome [7] 398950 0
Change in fasting serum total cholesterol level measured by blood serum analysis
Timepoint [7] 398950 0
Baseline and 26 weeks after enrolment
Secondary outcome [8] 399687 0
Change in fasting serum triglyceride level measured by blood serum analysis
Timepoint [8] 399687 0
Baseline and 26 weeks after enrolment
Secondary outcome [9] 399688 0
Change in fasting serum low density lipoprotein (LDL) cholesterol level measured by blood serum analysis
Timepoint [9] 399688 0
Baseline and 26 weeks after enrolment
Secondary outcome [10] 399689 0
Change in fasting serum high density lipoprotein (HDL) cholesterol level measured by blood serum analysis
Timepoint [10] 399689 0
Baseline and 26 weeks after enrolment
Secondary outcome [11] 399690 0
Chase in fasting blood glucose measured by blood serum analysis
Timepoint [11] 399690 0
Baseline and 26 weeks after enrolment
Secondary outcome [12] 399691 0
Change in insulin resistance as measured by the HOMA-IR, from blood serum analysis
Timepoint [12] 399691 0
Baseline and 26 weeks after enrolment
Secondary outcome [13] 399692 0
Change in HBa1c as measured by blood serum analysis
Timepoint [13] 399692 0
Baseline and 26 weeks after enrolment
Secondary outcome [14] 399693 0
Change in liver fibrosis as estimated by fibroscan
Timepoint [14] 399693 0
Baseline and 26 weeks after enrolment
Secondary outcome [15] 399947 0
Change in liver fibrosis as estimated by FIB-4 calculator
Timepoint [15] 399947 0
Baseline and 26 weeks after enrolment
Secondary outcome [16] 399948 0
Change in liver fibrosis as estimated by NAFLD fibrosis score calculator
Timepoint [16] 399948 0
Baseline and 26 weeks after enrolment
Secondary outcome [17] 399949 0
Change in stool bacterial microbiome as assessed by 16sRNA gene sequencing of stool specimens
Timepoint [17] 399949 0
Baseline and 26 weeks after enrolment

Eligibility
Key inclusion criteria
Patients with a diagnosis of NAFLD with evidence of hepatic steatosis on liver ultrasound and/or Fibroscan CAP score of >260 dB/m and abnormal liver function tests.
Patients who are non-coffee drinkers or irregular coffee drinkers.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who regularly consume coffee
2. Patients with causes of liver disease other than NAFLD
3. Alcohol intake greater than 1 (female) or 2 (male) standard drinks per day
4. Patients with poorly controlled diabetes (i.e. HbA1c >9.5%)
5. Patients with diabetes who have had a recent change in diabetic treatment regimen within the last 3 months
6. Patients who have been involved in a NAFLD trial within the last 3 months
7. Patients with decompensated liver cirrhosis
8. Patients who have recently been on antibiotics within the last 3 months
9. Patients who are on medications known to potentially cause fatty liver
10. Patients with significant change in weight (>5%) within the last 3 months
11. Patients who have contraindications to MRI scanning or unable to have MRI scan for any other reason
12. Patients unable to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20081 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 34789 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 309230 0
Hospital
Name [1] 309230 0
Austin Health
Country [1] 309230 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of Gastroenterology, Austin Hospital
145 Studley Rd, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 310229 0
None
Name [1] 310229 0
Address [1] 310229 0
Country [1] 310229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309078 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 309078 0
145 Studley Rd, Heidelberg VIC, 3084
Ethics committee country [1] 309078 0
Australia
Date submitted for ethics approval [1] 309078 0
Approval date [1] 309078 0
06/07/2021
Ethics approval number [1] 309078 0

Summary
Brief summary
Non-alcoholic fatty liver disease (NAFLD) is increasing in prevalence worldwide. It can cause advanced fibrosis and lead to complications of cirrhosis and hepatocellular carcinoma (HCC). Current treatments for NAFLD revolve around weight loss and lifestyle modification without any approved drug therapies in Australia.

Coffee consumption is thought to be beneficial in patients with NAFLD. It has been associated with reduced prevalence of advanced fibrosis in patients with NAFLD through epidemiological and cross-sectional studies.

Our study is a randomized controlled trial aiming to assess the effect of moderate coffee consumption on patients with NAFLD, looking at the percentage change in hepatic steatosis as measured by MRI over 26 weeks. Participants at baseline will need to be non-regular coffee drinkers. Participants will be randomised into 2 groups. The coffee group will be required to consume 2-3 coffees per day. Coffee pods and coffee machines will be supplied for the duration of the trial. All participants will receive standard lifestyle modification advice at commencement. Other parameters will also be assessed during the trial including anthropometric measures, biochemical markers and stool microbiome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112898 0
A/Prof Paul Gow
Address 112898 0
Austin Health
145 Studley Rd, Heidelberg, VIC, 3084.
Country 112898 0
Australia
Phone 112898 0
+61 3 9496 5353
Fax 112898 0
Email 112898 0
[email protected]
Contact person for public queries
Name 112899 0
A/Prof Paul Gow
Address 112899 0
Austin Health
145 Studley Rd, Heidelberg, VIC, 3084.
Country 112899 0
Australia
Phone 112899 0
+61 3 9496 5353
Fax 112899 0
Email 112899 0
[email protected]
Contact person for scientific queries
Name 112900 0
A/Prof Paul Gow
Address 112900 0
Austin Health
145 Studley Rd, Heidelberg, VIC, 3084.
Country 112900 0
Australia
Phone 112900 0
+61 3 9496 5353
Fax 112900 0
Email 112900 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?
De-identified participant data collected from trial.
When will data be available (start and end dates)?
After completion of study and publication of results, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Subject to approvals by Principal Investigator, can be contacted via email: [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.