A low-energy total diet replacement program demonstrates a favorable safety profile and improves liver disease severity in nonalcoholic steatohepatitis.

Abstract

Low-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. In 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. A 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. The intervention demonstrates high adherence, favorable safety profile, and promising efficacy as a treatment for NASH.