None listed
Conditions
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.
Interventions
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
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.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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
Outcome results
None listed