Effect of Indo‐Mediterranean diet versus calorie‐restricted diet in children with non‐alcoholic fatty liver disease: A pilot randomized control trial.

Summary: Background: Dietary interventions and increased physical activity are the cornerstones for management of the paediatric non‐alcoholic fatty liver disease (NAFLD). Though, no specific diet has been proven superior, Indo‐Mediterranean diet (IMD) has shown promise in adult literature. Thus, we aimed to compare the effect of IMD and a standard calorie‐restricted diet (CRD) in Indian overweight children and adolescents with biopsy‐proven NAFLD. Methods: Thirty‐nine consecutive biopsy‐proven NAFLD children between the ages of 8 and 18 years were randomized into either IMD or CRD for 180 days, and various parameters were evaluated at baseline and then after 180 days (NCT05073588). Results: A total of 34 subjects (18 in IMD and 16 in CRD group) completed the study. There was a significantly higher decrease in controlled attenuation parameter (CAP) values (as a marker of hepatic steatosis; on transient elastography) (95% CI: 4.2–73.4, p = 0.042), weight (95% CI: 0.75–5.5, p = 0.046) and body mass index (BMI) (95% CI: 0.21–2.05, p = 0.014) (but not in Pediatric NAFLD Fibrosis Index or PNFI; as a marker of hepatic fibrosis) in IMD group compared to the CRD group. Liver stiffness measurement, serum cholesterol and low‐density lipoprotein levels and HOMA‐IR decreased only in the IMD group (p < 0.001). Our statistical model showed that delta‐Weight was the only independent variable associated with delta‐CAP. Conclusion: Both IMD and CRD can improve the various anthropometric, clinical, imaging and biochemical parameters but IMD was superior to CRD in terms of reducing CAP values and weight/BMI over 180 days in overweight/obese NAFLD children. [ABSTRACT FROM AUTHOR]