This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis.
The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis.
Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body.
The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis
BMI ≥ 30 Kg/m2 or abdominal circumference (waist) >94 cm in men and >80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome
Age range between 18 and 70 years, both sexes
Diagnosis of hepatic steatosis, formulated on the basis of fibroscan [CAP (controlled attenuation parameter) > 238 dB/m(decibel/meter)], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).
Normal and underweight subjects
Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria
Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
Pregnancy or lactation
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
Francesco Russo
Collaborator
Giuseppe, Riezzo
Collaborator
Michele, Linsalata
Collaborator
Antonella, Orlando
Collaborator
Benedetta, D Attoma
Collaborator
Laura, Prospero
Collaborator
Antonia, Ignazzi
Collaborator
Sara, De Nucci
Collaborator
Raffaele, Cozzolongo
Collaborator
Vito, Giannuzzi
Collaborator
Maria, De Angelis
Collaborator
Giusy Rita, Caponio
Collaborator
Oronzo, Milella
Collaborator
Gianluigi, Giannelli
Collaborator