search
Back to results

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

Primary Purpose

Permeability; Increased, NAFLD, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ketogenic Diet
Sponsored by
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Permeability; Increased focused on measuring obesity, Gut permeability, NAFLD, Ketogenic diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irccs Saverio de BellisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention arm with VLCKD

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
September 27, 2023
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05477212
Brief Title
Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
May 28, 2024 (Anticipated)
Study Completion Date
May 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Permeability; Increased, NAFLD, Obesity
Keywords
obesity, Gut permeability, NAFLD, Ketogenic diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention arm with VLCKD
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic Diet
Intervention Description
all patients will receive a very low calorie ketogenic diet
Primary Outcome Measure Information:
Title
Gut permeability
Description
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
Time Frame
6 weeks
Title
Gut Dysbiosis
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni De Perogla, Prof
Phone
0804994635
Email
giovanni.depergola@irccsdebellis.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni De Pergola, Prof
Organizational Affiliation
IRCCS "Saverio de Bellis"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irccs Saverio de Bellis
City
Castellana Grotte
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni De Pergola, Professor
Phone
0804994635
Email
giovanni.depergola@irccsdebellis.it
First Name & Middle Initial & Last Name & Degree
Sara De Nucci, Dr
Phone
0804994635
Email
sa.denucci@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29984492
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 revealed by a lipid challenge and is linked to inflammation and type 2 diabetes. J Pathol. 2018 Oct;246(2):217-230. doi: 10.1002/path.5134. Epub 2018 Aug 28.
Results Reference
result
PubMed Identifier
28049662
Citation
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):127-135. doi: 10.3945/ajcn.116.131110. Epub 2016 Nov 9.
Results Reference
result
PubMed Identifier
32922055
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 2020.
Results Reference
result
PubMed Identifier
28931850
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):11955. doi: 10.1038/s41598-017-12109-9.
Results Reference
result
PubMed Identifier
33882506
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 Diet: A Systematic Review and Meta-Analysis. Obes Facts. 2021;14(2):222-245. doi: 10.1159/000515381. Epub 2021 Apr 21.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs