Summary: In this small exploratory randomised controlled trial of 17 adults with compensated cirrhosis due to metabolic dysfunction-associated steatotic liver disease (CC-MASLD) and obesity, a 12-week low-energy (880 kcal/day) total diet replacement programme with stepped food reintroduction produced a between-group weight loss of -11.9 kg (95% CI -17.2 to -6.6; p<0.001) at 24 weeks and significant reductions in liver fat, with no serious adverse events or hepatic decompensation. As a signal-generating feasibility study stopped early for slow recruitment, it demonstrates safety and plausibility rather than confirmed efficacy.
PICO Summary
| Element | Detail |
|---|---|
| Population | 17 adults with compensated cirrhosis due to MASLD and obesity (36% female; median age 58 years); single tertiary hepatology centre, United Kingdom; exploratory RCT randomised 2:1, stopped early for slow recruitment. |
| Intervention | Remote one-to-one dietetic support with a low-energy total diet replacement programme (880 kcal/day, 80 g protein/day) for 12 weeks, then stepped food reintroduction over a further 12 weeks (n=11). |
| Comparison | Standard of care (standard dietary advice) (n=6). |
| Outcome | Between-group weight change at 24 weeks -11.9 kg (95% CI -17.2 to -6.6; p<0.001). Iron-corrected T1 -149.9 ms (95% CI -258.1 to -41.7; p=0.01) and liver steatosis -6% (95% CI -11.3 to -0.6; p=0.03). No between-group difference in liver stiffness (0.2 kPa, 95% CI -1.1 to 1.6), physical performance test (1.5 points, 95% CI -1.9 to 4.9; p=0.70) or liver frailty index (0, 95% CI -0.6 to 0.6; p=0.97). Absolute fat-free mass fell (-3.2 kg; p=0.04) while relative fat-free mass rose (5.4%; p=0.046). Liver biochemistry remained stable; no safety thresholds met; no serious adverse events. No ARR/NNT reported. |
Severe energy restriction in MASLD cirrhosis
Exploratory RCT · MASLD cirrhosis + obesity · 24 weeks
A supervised 880 kcal/day protein-preserving diet replacement programme drove large weight loss and reduced liver fat without decompensation or serious adverse events. As a 17-patient feasibility RCT stopped early, it signals safety and plausibility, not confirmed efficacy.
Expert Commentary
This trial is best read as a safety and feasibility signal rather than proof of efficacy, and the authors frame it that way. Severe energy restriction has long been avoided in cirrhosis for fear of provoking decompensation or muscle wasting, so the central reassurance here is that liver biochemistry stayed stable, no predefined safety threshold was crossed, and no serious adverse events or decompensation were recorded. The weight loss was substantial and the reductions in iron-corrected T1 and steatosis are biologically coherent, while liver stiffness, physical performance and frailty were unchanged over this short horizon. The headline limitation is size and design: only 17 participants were randomised at a single centre, recruitment stopped early, and the dietary intervention was inherently unblinded, so these estimates are fragile and the confidence intervals wide. The fall in absolute fat-free mass, even as its relative proportion improved, deserves attention given sarcopenia risk in this group. Can I use this with my patients? Not yet as a routine prescription, but it supports cautiously offering a supervised, protein-preserving low-energy programme to a carefully selected patient with compensated MASLD cirrhosis and obesity, within a monitored setting. A larger adequately powered trial with hard outcomes is needed before this becomes standard advice.
References
Koutoukidis DA, Jebb SA, Tomlinson JW, Mozes FE, Pavlides M, Lacharie M, et al. Severe dietary energy restriction for compensated cirrhosis due to metabolic dysfunction-associated steatotic liver disease: a randomised controlled trial. J Cachexia Sarcopenia Muscle. 2025;16(3):e13783. doi:10.1002/jcsm.13783