Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
NCT ID: NCT05477212
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-04-28
2025-05-28
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
Ketogenic Diet
all patients will receive a very low calorie ketogenic diet
Interventions
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Ketogenic Diet
all patients will receive a very low calorie ketogenic diet
Eligibility Criteria
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Inclusion Criteria
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).
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
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Francesco Russo
UNKNOWN
Giuseppe, Riezzo
UNKNOWN
Michele, Linsalata
UNKNOWN
Antonella, Orlando
UNKNOWN
Benedetta, D Attoma
UNKNOWN
Laura, Prospero
UNKNOWN
Antonia, Ignazzi
UNKNOWN
Sara, De Nucci
UNKNOWN
Raffaele, Cozzolongo
UNKNOWN
Vito, Giannuzzi
UNKNOWN
Maria, De Angelis
UNKNOWN
Giusy Rita, Caponio
UNKNOWN
Oronzo, Milella
UNKNOWN
Gianluigi, Giannelli
UNKNOWN
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
OTHER
Responsible Party
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Prof. Giovanni De Pergola, MD
Professor
Principal Investigators
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Giovanni De Pergola, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS "Saverio de Bellis"
Locations
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Irccs Saverio de Bellis
Castellana Grotte, BARI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NAFLDdietachetogenica
Identifier Type: -
Identifier Source: org_study_id
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