Abstract
Background
Lifestyle intervention is the mainstay therapy for Non-Alcoholic Fatty Liver Disease (NAFLD). We aimed to assess the efficacy of an intensive (9 contact points in 6 months) weight-loss intervention among patients with obesity (BMI 25–39.9 kg/m2) and NAFLD in north India.
Methods
A total of 140 patients (18–60 years) with obesity and NAFLD were randomized into intervention (n = 70) and control (n = 70) groups, at a tertiary-care hospital. Weight, anthropometric parameters, Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM), liver enzymes, grade of fatty liver and HOMA-IR were measured at baseline (T0) and 6 months (T6). There was a high drop-out, exacerbated by the Covid-19 pandemic. Completers comprised of 59 participants (n = 30 intervention, n = 29 control). Intention to treat analysis was done.
Results
At T6, ALT normalized in significantly higher (p = 0.03) number of cases in the intervention arm (66.7%) versus control arm (18.2%). No significant improvement was seen in other metabolic, ultrasound or anthropometric outcomes. Weight (p < 0.001), AST (p = 0.01), ALT (p = 0.02), body fat% (p < 0.001), WC (p < 0.001) and CAP (p < 0.001) significantly improved within the intervention arm along with a trend of improvement in steatosis and HOMA-IR. Control group showed significant decrease in weight (p < 0.001), WC (p < 0.001) and CAP (p = 0.02). Twice the number of patients in intervention arm (46.7%) lost ≥5% weight, compared to control arm (24.1%) (p = 0.07).
Conclusion
The intensive weight-loss intervention was not effective in improving the treatment outcomes among patients with obesity and NAFLD. However, given the potential of our intervention, we recommend larger trials with more intensive weight-loss interventions.
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Data availability
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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Acknowledgements
We acknowledge University Grants Commission for providing Junior Research fellowship to Mrs. Charu Arora. [(UGC Reference number- 1332 (NET-DEC 2014))].
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CA: Data collection, data analysis, writing of the manuscript; AM: concept and design of the paper, data analysis and interpretation, critically reviewing and finalizing the manuscript; PR: Corresponding author, concept and design of the paper, finalization of the paper; VS: Statistical analysis and data interpretation, critically revising the manuscript; NS: Data collection, analysis and interpretation of dietary data; Shalimar: Data collection, critical review of paper; SND: Critical review of paper; NKV: Revising and reviewing the manuscript.
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The study was approved by the Institute Ethics Committee (IEC- 434/04.08.2017).
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Arora, C., Malhotra, A., Ranjan, P. et al. Effect of intensive weight-loss intervention on metabolic, ultrasound and anthropometric parameters among patients with obesity and non-alcoholic fatty liver disease: an RCT. Eur J Clin Nutr 76, 1332–1338 (2022). https://doi.org/10.1038/s41430-022-01111-8
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DOI: https://doi.org/10.1038/s41430-022-01111-8
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