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

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other)

Overall Status

Recruiting

CT.gov ID

NCT05477212

Collaborator

Francesco Russo (Other), Giuseppe, Riezzo (Other), Michele, Linsalata (Other), Antonella, Orlando (Other), Benedetta, D Attoma (Other), Laura, Prospero (Other), Antonia, Ignazzi (Other), Sara, De Nucci (Other), Raffaele, Cozzolongo (Other), Vito, Giannuzzi (Other), Maria, De Angelis (Other), Giusy Rita, Caponio (Other), Oronzo, Milella (Other), Gianluigi, Giannelli (Other)

Enrollment

Location

Arm

6.1

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Permeability; Increased NAFLD Obesity	Dietary Supplement: Ketogenic Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 28, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Dietary Supplement: Ketogenic Diet all patients will receive a very low calorie ketogenic diet

Arm

Intervention/Treatment

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

Dietary Supplement: Ketogenic Diet

all patients will receive a very low calorie ketogenic diet

Outcome Measures

Primary Outcome Measures

Gut permeability [6 weeks]
examine the influence of obesity on possible alterations (if any) in intestinal permeability. subjects drank a sugar test solution containing 10 g of lactulose, 5 g of mannitol, and 40 g of sucrose in a volume of 100 ml. Urine samples were collected up to 5 h after administration. . Te percentage of ingested La (%La), Ma (%Ma), and Su (%Su) were evaluated in urine, and the La/Ma ratio was calculated for each sample. Patients with a La/Ma ratio higher than 0.030 were considered as having an altered gut permeability
Gut Dysbiosis [6 weeks]
evaluate the impact of the low-calorie and ketogenic diet on possible alterations of the intestinal microbiome. The dysbiosis test is based on urinary quantification of two metabolites deriving from the decomposition of tryptophan, skatole (3-methyl-indole), and indican. Urinary indican and skatole were considered normal at values lower than 10 mg/L and 10 µg/L, respectively. Urinary concentrations of indican and skatole higher than 20 mg/L and 20 µg/L indicate the presence of fermentative and putrefactive grade I dysbiosis, respectively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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