protocolSection identificationModule nctId: NCT06329349, orgStudyIdInfo id: EK VP57/0/2023, briefTitle: Metabolic Flexibility to Predict Lifestyle Interventions Outcomes, acronym: MEPHISTO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Ministry of Health, Czech Republic, collaborators name: EXCELES LX22NPO5104, CarDia, descriptionModule briefSummary: Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 randomized cross-over, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Combined Exercise + Diet, outcomesModule primaryOutcomes measure: Change in metabolic flexibility (MetFlex (ΔRQ 200-0)), primaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Glucose tolerance relate to primary outcomes changes, secondaryOutcomes measure: HbA1c relate to primary outcomes changes, secondaryOutcomes measure: Insulin sensitivity relate to primary outcomes changes, otherOutcomes measure: Microbiome composition relate to weight loss: exploratory outcome, otherOutcomes measure: Metabolomic signatures relate to weight loss: exploratory outcome, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital Kralovske Vinohrady, status: RECRUITING, city: Prague, zip: 10034, country: Czechia, contacts name: Jan Gojda, PhD, role: CONTACT, phone: +420267163031, email: jan.gojda@lf3.cuni.cz, contacts name: Katerina Koudelkova, MD, role: CONTACT, phone: +420267163031, email: katerina.koudelkova@fnkv.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Third Medical Faculty,Charles University, status: RECRUITING, city: Prague, zip: 10084, country: Czechia, contacts name: Michaela Šiklová, PhD, role: CONTACT, phone: +420267102222, email: michaela.siklova@lf3.cuni.cz, contacts name: PhD, role: CONTACT, phone: +420267163031, email: jan.gojda@lf3.cuni.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Faculty of Sports Science, status: RECRUITING, city: Prague, zip: 16000, country: Czechia, contacts name: Michal Šteffl, PhD, role: CONTACT, phone: +420220172072, email: michal.steffl@ftvs.cuni.cz, contacts name: Tomáš Větrovský, PhD, role: CONTACT, phone: +420220172072, email: tomas.vetrovsky@ftvs.cuni.cz, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False