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

NCT05477212 | Recruiting

• 1 other identifier: NAFLDdietachetogenica
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Permeability; Increased; NAFLD; Obesity

Keywords

obesity; Gut permeability; NAFLD; Ketogenic diet

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

intervention arm with VLCKD

EXPERIMENTAL

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

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

all patients will receive a very low calorie ketogenic diet

intervention arm with VLCKD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Normal and underweight subjects
• Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
• Pregnancy or lactation

Sponsors & Collaborators

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

Study Sites (1)

Irccs Saverio de Bellis

Castellana Grotte, BARI, 70013, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 29984492 RESULT

• 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.

  PMID: 28049662 RESULT

• 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.

  PMID: 32922055 RESULT

• 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.

  PMID: 28931850 RESULT

• 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.

  PMID: 33882506 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Giovanni De Pergola, Prof

  IRCCS "Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni De Perogla, Prof

CONTACT

0804994635; giovanni.depergola@irccsdebellis.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 28, 2022
• Study Start: April 28, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)