protocolSection identificationModule nctId: NCT06389851, orgStudyIdInfo id: NAFLD-LYCOPENE, briefTitle: Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, class: OTHER, collaborators name: Dr. Di Stasi Vincenza, collaborators name: Dr. Donvito Rosanna, collaborators name: Dr. Cozzolongo Raffaele, collaborators name: Dr. Giannuzzi Vito, collaborators name: Dr. Zappimbulso Marianna, collaborators name: Dr. Shahini Endrit, collaborators name: Dr. Notarnicola Maria, collaborators name: Dr. Russo Francesco, collaborators name: Dr. Riezzo Giuseppe, collaborators name: Dr. Donghia Rossella, collaborators name: Dr. Cesternino Anna Maria, collaborators name: Dr. Cici Rosalisa, collaborators name: Dr. Cerabino Nicole, collaborators name: Dr. Martina Di Chito, collaborators name: Dr. Pesole Pasqua Letizia, collaborators name: Dr. Coletta Sergio, collaborators name: Dr. Stabile Dolores, collaborators name: Dr. Ancona Anna, collaborators name: Dr. D'Attoma Benedetta, collaborators name: Dr. Ignazzi Antonia, collaborators name: Dr. De Nunzio Valentina, collaborators name: Dr. Tatoli Rossella, collaborators name: Dr. Pinto Giuliano, descriptionModule briefSummary: The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;* intestinal barrier;* body composition;* intestinal microbiota;* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD., conditionsModule conditions: NAFLD, conditions: IBS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study evaluates the effects on NAFLD, Intestinal Integrity and Microbiota of a diet enriched with tomatoes compared to a diet without tomatoes, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Case Group - Tomato-free diet, interventions name: Experimental: Case group - Diet enriched with tomatoes, outcomesModule primaryOutcomes measure: The effect of intervention on CAP value (Controlled Attenuation Parameter), primaryOutcomes measure: The effect of intervention on FLI value (fatty liver index), primaryOutcomes measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, primaryOutcomes measure: The effect of the intervention on the integrity of the intestinal barrier, primaryOutcomes measure: The effect of the intervention on the microbiota, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Saverio de Bellis, city: Castellana Grotte, state: Bari, zip: 70013, country: Italy, geoPoint lat: 40.88643, lon: 17.16549, hasResults: False