Feasibility of a very low calorie diet in NAFLD
Research type
Research Study
Full title
Is a very low calorie diet an acceptable therapy to achieve a target weight loss in patients with advanced non-alcoholic fatty liver disease?
IRAS ID
241661
Contact name
Kate Hallsworth
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Not allocated yet, To be registered on local NIHR CRN portfolio
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) affects up to 1-in-3 adults in Western countries. It represents a spectrum of conditions spanning from simple fatty liver through to non-alcoholic steatohepatitis (NASH- liver inflammation), life threatening cirrhosis, liver cancer and liver failure, and has become a common cause of liver transplant. Risk factors include: increasing age, being overweight or obese, inactivity, Type 2 diabetes mellitus (T2DM) or pre-diabetes, diet and family history. Most patients have no symptoms at diagnosis.
Currently there are no approved drugs to specifically target NAFLD- the main treatment is lifestyle changes with weight loss being the key to improving liver health. Lifestyle interventions designed for weight loss through reduced energy intake in NAFLD have led to reductions in liver fat or between 42 and 81% with the greatest reductions in liver fat observed in people who lose the most weight.
This study aims to assess the feasibility and acceptability of an 8-week very low calorie diet in patients with advanced NAFLD. We intend to investigate how many patients respond to an invite to take part in this study and how many who take part complete the diet and maintain their weight loss. We are interested in how much weight patients lose during the intervention and whether they are able to return to normal eating in the following six months. We aim to capture patients' views including what makes it easy or difficult to stick to the diet. This will help us decide whether this type of intervention could be provided on a larger scale to assess its effectiveness, and if effective be used as part of standard clinical care.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0179
Date of REC Opinion
30 Jul 2018
REC opinion
Further Information Favourable Opinion