Lipids & metabolic liver disease

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

Obesity (Silver Spring)Published Single-arm trial

An erratum to this article was published (Obesity (Silver Spring), Oct 2023 ↗)

Authors' conclusion

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

Study context

Population
Adults with nonalcoholic steatohepatitis (NASH), fibrosis and obesity14 completed
Participants
16 adults
Comparison
Low-energy (880 kcal/d) total diet replacement for 12 weeks, then stepped food reintroduction for 12 weeks; vs baseline
  • Total diet replacementn = 16
Outcome
Liver disease severity vs baseline
Follow-up
24 weeks
Methodological details24-week, blinded outcome assessment, remote dietetic support
  • 24-week
  • Blinded outcome assessment
  • Remote dietetic support

Main finding

As reported in the abstract

MRI-PDFF reduction vs baseline
13.1% (95% CI: 8.9%-16.7%)
cT1 reduction vs baseline
159 milliseconds (95% CI: 108-216.5)
MRE liver stiffness reduction vs baseline
0.4 kPa (95% CI: 0.1-0.8)
VCTE liver stiffness reduction vs baseline
3.9 kPa (95% CI: 2.6-7.2)
Clinically relevant reduction in MRI-PDFF (≥30%)
93%
Clinically relevant reduction in cT1 (≥88 milliseconds)
77%
Clinically relevant reduction in MRE liver stiffness (≥19%)
57%
Clinically relevant reduction in VCTE liver stiffness (≥19%)
93%

Further findings

Weight loss · 24 weeks

Weight loss
15% (95% CI: 11.2%-18.6%)

Completion

Completed the intervention
14 (87.5%)

Safety

Serious intervention-related adverse events
0
Liver biochemical markers improved

Original publication

A low‐energy total diet replacement program demonstrates a favorable safety profile and improves liver disease severity in nonalcoholic steatohepatitis. Obesity (Silver Spring). Published 27 June 2023. doi:10.1002/oby.23793

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