Affiliation:
1. Nuffield Department of Primary Care Health Sciences University of Oxford Oxford UK
2. National Institute for Health and Care Research Oxford Biomedical Research Centre Oxford UK
3. Oxford Centre for Clinical Magnetic Resonance Research, Radcliffe Department of Medicine University of Oxford Oxford UK
4. Oxford Centre for Diabetes, Endocrinology and Metabolism, Radcliffe Department of Medicine University of Oxford Oxford UK
5. Department of Gastroenterology and Hepatology John Radcliffe Hospital, Oxford University Hospitals National Health Service Foundation Trust Oxford UK
6. Oviva London UK
Abstract
AbstractObjectiveLow‐energy diets are used to treat obesity and diabetes, but there are fears that they may worsen liver disease in patients with nonalcoholic steatohepatitis (NASH) and significant‐to‐advanced fibrosis.MethodsIn this 24‐week single‐arm trial, 16 adults with NASH, fibrosis, and obesity received one‐to‐one remote dietetic support to follow a low‐energy (880 kcal/d) total diet replacement program for 12 weeks and stepped food reintroduction for another 12 weeks. Liver disease severity was blindly evaluated (magnetic resonance imaging proton density fat fraction [MRI‐PDFF], iron‐corrected T1 [cT1], liver stiffness on magnetic resonance elastography [MRE], and liver stiffness on vibration‐controlled transient elastography [VCTE]). Safety signals included liver biochemical markers and adverse events.ResultsA total of 14 participants (87.5%) completed the intervention. Weight loss was 15% (95% CI: 11.2%–18.6%) at 24 weeks. Compared with baseline, MRI‐PDFF reduced by 13.1% (95% CI: 8.9%–16.7%), cT1 by 159 milliseconds (95% CI: 108–216.5), MRE liver stiffness by 0.4 kPa (95% CI: 0.1–0.8), and VCTE liver stiffness by 3.9 kPa (95% CI: 2.6–7.2) at 24 weeks. The proportions with clinically relevant reductions in MRI‐PDFF (≥30%), cT1 (≥88 milliseconds), MRE liver stiffness (≥19%), and VCTE liver stiffness (≥19%) were 93%, 77%, 57%, and 93%, respectively. Liver biochemical markers improved. There were no serious intervention‐related adverse events.ConclusionsThe intervention demonstrates high adherence, favorable safety profile, and promising efficacy as a treatment for NASH.
image
Subject
Nutrition and Dietetics,Endocrinology,Endocrinology, Diabetes and Metabolism,Medicine (miscellaneous)