The effect of the Spanish Ketogenic Mediterranean Diet on nonalcoholic fatty liver disease: a pilot study.

The "Spanish Ketogenic Mediterranean Diet" (SKMD) has been shown to be an effective and safe way to cure patients suffering from metabolic syndrome (MS). Keeping in mind that nonalcoholic fatty liver disease (NAFLD) is closely associated with MS, the purpose of this study was to evaluate the potential therapeutic properties under free living conditions of the SKMD in patients with MS (following the International Diabetes Federation [IDF] consensus guidelines) and NAFLD (suspected by using a cutoff value of alanine aminotransferase [ALT] levels of >40 U/L and confirmed by abdominal ultrasonography) over a 12-week period. A prospective study was carried out in 14 obese men meeting the inclusion criteria and whose body mass index (BMI) and age were 36.58±0.54 kg/m² and 41.18±2.28 years, respectively. Statistical differences between the parameters studied before and after administration of the SKMD (week 0 and 12) were analyzed by paired Student's t test (continuous variables) and the χ² test (discontinuous variables). P<.05 was considered statistically significant. There was an extremely significant (P<.001) improvement in body weight (from 109.79 kg to 95.86 kg), low-density lipoprotein-cholesterol (from 123.43 mg/dL to 100.35 mg/dL), ALT (from 71.92 U/L to 37.07 U/L), aspartate aminotransferase (from 47.71 U/L to 29.57 U/L), steatosis degree (complete fatty liver regression was observed in 21.4% of the patients, and an overall reduction was found in 92.86% of the patients), and all the parameters studied associated with the MS: BMI (from 36.99 kg/m² to 32.42 kg/m²), waist circumference (from 114.01 cm to 98.59 cm), fasting plasma glucose (from 118.57 mg/dL to 90.14 mg/dL), triacylglycerols (from 232.64 mg/dL to 111.21 mg/dL), high-density lipoprotein-cholesterol (HDLc) (from 42.81 mg/dL to 58.71 mg/dL), systolic blood pressure (from 142.86 mm Hg to 125.36 mm Hg), and diastolic blood pressure (from 89.64 mm Hg to 77.86 mm Hg). After the diet all the subjects were free of MS according to the IDF definition, and 100% of them had normal triacylglycerols and HDLc levels, in spite of the fact that 100% of them still had a BMI of >30 kg/m². We conclude that the SKMD could be an effective and safe way to treat patients suffering from MS and the associated NAFLD.