Non-alcoholic fatty liver disease Digestive System Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
All interested and eligible participants (± relatives/friends) will have the chance to discuss the 8-week vLCD in detail with a member of the research team prior to obtaining informed consent. The maj
one of the liquid replacement meals per day will be replaced with normal food in the first week with intensive training on portion size. Two normal meals will be instituted during week 2. If desired,
Sponsors
Newcastle upon Tyne Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-70 years 2. NASH with = NIH NASH CRN stage 1 fibrosis confirmed on liver biopsy or a clinical diagnosis of NAFLD with imaging evidence of steatosis with a raised NAFLD fibrosis score [>-1.455] 3. Weight stable (+/-3%) since biopsy/non-invasive assessment of liver 4. BMI>27kg/m2 5. Capacity to provide informed consent 6. Ability to write and converse in English without the assistance of an interpreter
Exclusion criteria
Exclusion criteria: 1. Weight loss of >2kg in the past month 2. Evidence of co-existent liver disease (e.g. autoimmune liver disease, viral hepatitis, alpha-1 anti-trypsin deficiency, haemochomatosis or Wilson’s disease) 3. Current treatment with anti-obesity drugs 4. Diagnosed/previous eating disorder or purging 5. Excessive alcohol consumption (>21 units/week for males; >14 units/week for females) 6. Insulin use 7. Known cancer 8. Myocardial infarction within 6 months 9. Pregnant/considering pregnancy 10. Previous hospital admission for depression or current antipsychotic drug medication 11. Learning difficulties 12. Decompensated NASH cirrhosis (Child Pugh score = 7)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Weight measured using a digital column scale (SECA, UK) at baseline, 7 days post baseline and fortnightly thereafter until 8 weeks 2. Patient experiences and views of the intervention analysed by a 1-1 semi-structured interview conducted at the end of the intervention (visit 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate: the number of patients approached and information sheets given out compared to the number of patients who take part 2. Retention rate monitored by attendance of fortnightly study visits 3. Weight measured using a digital column scale (SECA, UK) at monthly visits over 6 months after the intervention 4. Liver enzymes (ALT, AST, GGT and Alkaline Phosphatase), lipid profile (cholesterol, HDLs, LDLs and triglycerides), fasting blood glucose and inflammatory cytokines analysed by routinely available assays at every study visit 5. Body composition measured using an 8-point Bioelectrical Impedance Analysis machine at baseline and at visit 6 (post 8 weeks of total diet replacement) 6. Adverse effects reported by participants at any time during the 8-week intervention | — |
Countries
England, United Kingdom
Contacts
Public ContactJadine Scragg
Outcome results
None listed