LiFT: Liver fibrosis after low-energy treatment in steatohepatitis
Research type
Research Study
Full title
Changes in LIver Fibrosis and inflammation estimated non-invasively after Treatment with a low-energy total diet replacement programme in people with non-alcoholic steatohepatitis: a single-arm trial
IRAS ID
269633
Contact name
Dimitrios Koutoukidis
Contact email
Sponsor organisation
University of Oxford /Clinical Trials and Research Governance
ISRCTN Number
ISRCTN12900952
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background: The building up of fat in the liver can cause inflammation and scarring. This serious condition is called non-alcoholic steatohepatitis (NASH). NASH can lead to liver problems and heart disease. It affects almost 4 million people in Britain and about 80-90% of them have obesity.
No drug is currently available to treat NASH. Weight loss programmes might improve NASH, but only if they lead to large weight loss. One programme that could achieve this on a large scale is a low-calorie diet with one-to-one support. In this programme, people only eat soups and shakes for 12 weeks (about 810 calories per day). Then, slowly over the next 12 weeks, they swap some soups and shakes for regular food. The support helps people stick to the programme and develop healthier eating habits. People lose weight rapidly and lower their risk of heart disease and type 2 diabetes. About half of the people with type 2 diabetes stop their medication. This may also be a good treatment for NASH, but there is some evidence that rapid weight loss may worsen scarring in the liver. Here we will test the programme in a small group of people with detailed monitoring of the health of their liver.
Aims: To measure the changes in the liver fibrosis and inflammation with non-invasive procedures in people with NASH after a total diet replacement programme.
Methods: We will recruit 16 people with obesity and NASH and ask them to follow the weight loss programme. We will do blood tests after 4 weeks to check for an early changes. At the start and after 3 and 6 months, participants will have a magnetic resonance imaging (MRI) scan and an ultrasound of their liver to see if there has been any further change in the health of their liver.
Importance: If the results indicate that the inflammation and fibrosis do not worsen in the short-term, we will plan a big trial to test if this programme is a good treatment for NASH.
Summary of Results:
Sixteen participants with non-alcoholic steatohepatitis and liver fibrosis took part in the study. Of those, 14 completed the study.• On average, participants lost 15% of their body weight at 6 months, with the majority of this being body fat.
• The regular blood tests showed that the diet was safe, as the liver function tests did not worsen in anyone at 24 weeks, but, instead, they significantly improved.
• The markers of liver disease based on the MRI/MRE and Fibroscan showed significant and persistent improvements.
• Markers that indicate the risk of developing heart disease including blood pressure and a measure of blood sugar levels called haemoglobin A1c, also significantly improved.
Overall, these exciting results show the potential of a “soups and shakes” diet to reverse how the disease progresses. We hope that the results of this research will bring a change in routine liver clinics and allow more frequent use of similar weight loss programmes.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1856
Date of REC Opinion
3 Jan 2020
REC opinion
Further Information Favourable Opinion