Meal Replacement Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease in Adolescents with Severe Obesity.
This clinical trial examined whether short-term meal replacement therapy (MRT) could reduce liver fat and improve metabolic markers in adolescents with severe obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). Seventeen participants aged 12–17 years (mean BMI ~40 kg/m²; mean hepatic fat fraction ~15.6%) completed a 4–8 week MRT program targeting a ~500 kcal/day caloric deficit and at least 5% BMI reduction. Liver fat was measured using magnetic resonance spectroscopy (MRS) at baseline and follow-up. The study found a mean 5.6% absolute reduction in BMI and a statistically significant decrease in hepatic fat fraction, along with improvements in insulin sensitivity, glucose area under the curve, and leptin levels. No significant change in alanine aminotransferase (ALT) was observed. Key limitations include the very small sample size (n=17), absence of a control group, and the short intervention duration, all of which substantially restrict generalizability. The authors conclude that MRT was associated with reductions in liver fat and metabolic improvements in this population and call for larger, controlled trials to assess MRT as part of a broader multimodal treatment strategy for adolescent MASLD.
Why this grade: While conducted in humans with objective MRS outcomes, the study lacks a control group and has a very small sample size (n=17), substantially limiting the strength of causal inference.
Background This clinical trial evaluated hepatic fat content and weight loss in adolescents with severe obesity and metabolic dysfunction-associated steatotic liver disease (MASLD) following short-term meal replacement therapy (MRT). Methods Adolescents aged 12-17 years with severe obesity (BMI ≥1.2 × 95th percentile or ≥35 kg/m 2 ) and magnetic resonance imaging-confirmed MASLD (hepatic fat fraction [HFF] ≥5%) completed a 4- to 8-week MRT program (∼500 kcal/day deficit) targeting ≥5% BMI reduction. Participants underwent 1 H-magnetic resonance spectroscopy at baseline and at follow-up, along with 2-hour mixed-meal tolerance testing. Results Seventeen adolescents [baseline mean (standard deviation or SD) BMI = 39.9 (4.1) kg/m 2 ; age = 16.0 (1.6) years; 65% male; HFF = 15.6 (5.1)%] demonstrated a mean absolute decrease in BMI of 5.6% [-2.23 kg/m 2 ; 95% confidence interval (CI): -2.45, -2.02; p p p = 0.012], glucose area under the curve (AUC) [-2.2 mg/dL (-3.2, -1.3); p = 0.021], and leptin AUC [-40.5 pg/mL (-57.1, -23.9); p = 0.009]. No significant difference in alanine aminotransferase was observed. Conclusions Short-term MRT was associated with reductions in liver fat and improvements in metabolic biomarkers among adolescents with MASLD. Large-scale trials are needed to evaluate the implementation of MRT as part of a multimodal treatment strategy in this population. [Clinical Trial Registration: Enhancing Weight Loss Maintenance with GLP-1 RA (BYDUREON™) in Adolescents With Severe Obesity, NCT02496611, https://clinicaltrials.gov/study/NCT02496611].
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