Effect of a Ketogenic Diet on Metabolic Dysfunction‐Associated Steatotic Liver Disease (<scp>MASLD</scp>) Progression: A Randomized Controlled Trial

Abstract

ABSTRACT Background Despite the popularity of a ketogenic diet, no randomized, controlled trials have evaluated its efficacy on metabolic dysfunction‐associated steatotic liver disease (MASLD) progression. Methods We conducted an 8‐week, open‐label, randomized controlled trial involving 24 patients with MASLD who were randomly assigned to either the home delivery ketogenic diet or a nutrition education program on adherence to the DASH diet. The primary outcome was a reduction in hepatic steatosis as measured by transient elastography. Results There were no significant differences between groups in liver stiffness and steatosis measurement after interventions. Subjects on a ketogenic diet had lost more weight than subjects in the control group at 8 weeks (mean change [95% CI], −6.16 [−7.22, −5.10] vs. −2.14 [−4.49, 0.21] kg; p = 0.001). The decrease in waist circumference, systolic blood pressure, fat mass, and visceral fat area was significantly greater among subjects on a ketogenic diet than among those in the control group. Laboratory parameters, including AST, triglyceride, and HDL were also significantly decreased among subjects on a ketogenic diet than among those in the control group. Conclusions A ketogenic diet produced a significantly greater weight loss (absolute difference, approximately 4%) than did the general lifestyle advice intervention for the first 8 weeks. A ketogenic diet was associated with a greater improvement in some risk factors for coronary heart disease and MASLD. However, a ketogenic diet did not reduce steatosis nor worsen MASLD progression. Longer and larger studies are required to determine the long‐term safety and efficacy of the ketogenic diet. Trial Registration: TCTR20220426005

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