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

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

NCT Number	NCT05477212
Lead Sponsor	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Collaborators: Francesco Russo, Giuseppe, Riezzo, Michele, Linsalata, Antonella, Orlando, Benedetta, D Attoma, Laura, Prospero, Antonia, Ignazzi, Sara, De Nucci, Raffaele, Cozzolongo, Vito, Giannuzzi, Maria, De Angelis, Giusy Rita, Caponio, Oronzo, Milella, Gianluigi, Giannelli
Conditions	Permeability; Increased, NAFLD, Obesity
Enrollment	30 participants
Start Date	2022-04-28
Primary Completion	2024-05-28 (estimated)
Study Completion	2025-05-28 (estimated)
Updated on ClinicalTrials.gov	2024-10-02