protocolSection identificationModule nctId: NCT06275906, orgStudyIdInfo id: NAFLD-POS5, briefTitle: Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters., acronym: NAFLD-POS5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-04-08, completionDateStruct date: 2026-04-08, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, class: OTHER, collaborators name: Russo Francesco, collaborators name: Cozzolongo Raffaele, collaborators name: Shahini Endrit, collaborators name: Zappimbulso Marianna, collaborators name: Giannuzzi Vito, collaborators name: De Nucci Sara, collaborators name: Rinaldi Roberta, collaborators name: Sila Annamaria, collaborators name: Tatoli Rossella, collaborators name: Cerabino Nicole, collaborators name: Donghia Rossella, collaborators name: Franco Isabella, collaborators name: Bianco Antonella, collaborators name: Curci Ritanna, collaborators name: Bagnato Claudia Beatrice, collaborators name: Sciarra Sabrina, collaborators name: Prospero Laura, collaborators name: Serino Grazia, collaborators name: Scalavino Viviana, collaborators name: Piccinno Emanuele, collaborators name: Pesole Pasqua Letizia, collaborators name: Coletta Sergio, collaborators name: Stabile Dolores, collaborators name: Riezzo Giuseppe, collaborators name: Ancona Anna, collaborators name: D'Attoma Benedetta, collaborators name: Ignazzi Antonia, descriptionModule briefSummary: The study in question is an interventional study with nutritional intervention.The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, 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: Obesity, conditions: IBS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean diet and moderate intensity physical exercise (outdoor walking)., outcomesModule primaryOutcomes measure: The effect of intervention on CAP value, primaryOutcomes measure: The effect of intervention on FLI value, primaryOutcomes measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk, primaryOutcomes measure: The effect of the intervention on the integrity of the intestinal barrier, secondaryOutcomes measure: The effect of the intervention on the Gastrointestinal Symptoms, secondaryOutcomes measure: The effect of the intervention on the Body Composition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: 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