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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477212
• Other study ID #: NAFLDdietachetogenica
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: May 28, 2024

Study information

• Verified date: September 2023
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: Giovanni De Perogla, Prof
• Phone: 0804994635
• Email: giovanni.depergola[@]irccsdebellis.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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

2. Age range between 18 and 70 years, both sexes

3. 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:

1. Normal and underweight subjects

2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria

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

4. Pregnancy or lactation

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity
• Permeability; Increased

Intervention

Dietary Supplement:
• Ketogenic Diet
all patients will receive a very low calorie ketogenic diet

Locations

Country	Name	City	State
Italy	Irccs Saverio de Bellis	Castellana Grotte	Bari

Sponsors (15)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis	Antonella, Orlando, Antonia, Ignazzi, Benedetta, D Attoma, Francesco Russo, Gianluigi, Giannelli, Giuseppe, Riezzo, Giusy Rita, Caponio, Laura, Prospero, Maria, De Angelis, Michele, Linsalata, Oronzo, Milella, Raffaele, Cozzolongo, Sara, De Nucci, Vito, Giannuzzi

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Damms-Machado A, Louis S, Schnitzer A, Volynets V, Rings A, Basrai M, Bischoff SC. Gut permeability is related to body weight, fatty liver disease, and insulin resistance in obese individuals undergoing weight reduction. Am J Clin Nutr. 2017 Jan;105(1):12 — View Citation

Genser L, Aguanno D, Soula HA, Dong L, Trystram L, Assmann K, Salem JE, Vaillant JC, Oppert JM, Laugerette F, Michalski MC, Wind P, Rousset M, Brot-Laroche E, Leturque A, Clement K, Thenet S, Poitou C. Increased jejunal permeability in human obesity is re — View Citation

Mkumbuzi L, Mfengu MMO, Engwa GA, Sewani-Rusike CR. Insulin Resistance is Associated with Gut Permeability Without the Direct Influence of Obesity in Young Adults. Diabetes Metab Syndr Obes. 2020 Aug 24;13:2997-3008. doi: 10.2147/DMSO.S256864. eCollection — View Citation

Muscogiuri G, El Ghoch M, Colao A, Hassapidou M, Yumuk V, Busetto L; Obesity Management Task Force (OMTF) of the European Association for the Study of Obesity (EASO). European Guidelines for Obesity Management in Adults with a Very Low-Calorie Ketogenic D — View Citation

Ott B, Skurk T, Hastreiter L, Lagkouvardos I, Fischer S, Buttner J, Kellerer T, Clavel T, Rychlik M, Haller D, Hauner H. Effect of caloric restriction on gut permeability, inflammation markers, and fecal microbiota in obese women. Sci Rep. 2017 Sep 20;7(1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut permeability	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	6 weeks
Primary	Gut Dysbiosis	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	6 weeks