RecruitingNot ApplicableNCT05477212

Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.

Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet on Diagnostic and Prognostic Markers in Liver Disease

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

30 participants

Start Date

Apr 28, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity NAFLD Permeability; Increased

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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).
Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
Pregnancy or lactation