Is a very low calorie diet an acceptable therapy to achieve a target weight loss in patients with advanced non-alcoholic fatty liver disease?

Not Applicable

Completed

• Conditions: on-alcoholic fatty liver disease; Digestive System; Fatty (change of) liver, not elsewhere classified

• Registration Number: ISRCTN85177264
• Lead Sponsor: ewcastle upon Tyne Hospital NHS Trust

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33094956/ (added 01/09/2021) 2020 Abstract results in https://pubmed.ncbi.nlm.nih.gov/32840677/ (added 06/09/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34326098/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Study Completion: 2020-04-07
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Weight measured using a digital column scale (SECA, UK) at baseline, 7 days post baseline and fortnightly thereafter until 8 weeks2. 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 Outcome Measures

Name	Time	Method
1. Recruitment rate: the number of patients approached and information sheets given out compared to the number of patients who take part2. Retention rate monitored by attendance of fortnightly study visits3. Weight measured using a digital column scale (SECA, UK) at monthly visits over 6 months after the intervention4. 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 visit5. 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