Adapting medical weight loss methods to the management of nonalcoholic fatty liver disease: A randomised control trial evaluating the effects of a very low energy diet on hepatic and metabolic outcomes in individuals with nonalcoholic fatty liver disease

Not Applicable

Recruiting

• Conditions: onalcoholic fatty liver disease; Nonalcoholic fatty liver disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12623000756628
• Lead Sponsor: St Vincent's Hospital Melboourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-11
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Individuals aged 18 – 70 who are able to provide consent
2.BMI 27kg/m2 to 35kg/m2
3.Elevated ALT and/or GGT
4.>= F1 fibrosis on liver biopsy
5.Liver fat on MRS >= 10%

Exclusion Criteria

1.Alcohol >2 SD/day for men and >1 SD/day for women
2.Other liver disease, i.e. viral hepatitis, autoimmune liver disease, haemochromatosis
3.Decompensated cirrhosis or cirrhosis with Fibroscan > 25kPa
4.Other significant medical or psychological issue that would preclude a diet; such as cardiac disease, lung disease or malignancy
5.Antibiotics, probiotics, corticosteroids, hormonal therapies or methotrexate within three months of baseline data collection, or current use of a GLP-1 agonist or insulin
6.Already lost >5% body weight or previous bariatric surgery
7.Participation in another interventional trial, or participation in another interventional trial within the last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in intra-hepatic lipid content on MRI[Week 12 post-intervention commencement]