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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Irccs Saverio de Bellis
RECRUITING
Castellana Grotte
Contact Information
Primary
Giovanni De Perogla, Prof
giovanni.depergola@irccsdebellis.it
0804994635
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2025-05-28
Participants
Target number of participants: 30
Treatments
Experimental: intervention arm with VLCKD
all patients will receive a very low calorie Ketogenic diet (VLCKD) and will be followed for all the time of the study, monitoring gut permeability, liver steatosis and microbiome composition
Sponsors
Collaborators: Sara, De Nucci, Giusy Rita, Caponio, Gianluigi, Giannelli, Giuseppe, Riezzo, Raffaele, Cozzolongo, Vito, Giannuzzi, Oronzo, Milella, Francesco Russo, Antonella, Orlando, Maria, De Angelis, Michele, Linsalata, Laura, Prospero, Antonia, Ignazzi, Benedetta, D Attoma
Leads: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

This content was sourced from clinicaltrials.gov