protocolSection identificationModule nctId: NCT06309121, orgStudyIdInfo id: PIC-11-24, briefTitle: Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents, acronym: PostOb, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Fundació Sant Joan de Déu, class: OTHER, descriptionModule briefSummary: This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat., conditionsModule conditions: Obesity, Childhood, conditions: Obesity, Adolescent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Postbiotic ABB C3, interventions name: Placebo, interventions name: Follow-up Postbiotic ABB C3 (Optional), outcomesModule primaryOutcomes measure: Incidence of Adverse Events, primaryOutcomes measure: Change in adiposity (% fat body mass), primaryOutcomes measure: Change in blood glycated hemoglobin (HbA1c) levels, secondaryOutcomes measure: Change in adiposity (% fat body mass), secondaryOutcomes measure: Change in blood glycated hemoglobin (HbA1c) levels, secondaryOutcomes measure: Change in BMI z-score, secondaryOutcomes measure: Change in body composition, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in lipid profile (triglycerides, cholesterol), secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in Beck Depression Inventory-II (BDI-2), secondaryOutcomes measure: Change in Beck Anxiety Inventory-II (BAI-2), otherOutcomes measure: Change in gut microbial abundance and diversity, otherOutcomes measure: Change in plasma metabolite concentrations, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Sant Joan de Déu, status: RECRUITING, city: Barcelona, zip: 08950, country: Spain, contacts name: Marta Ramon Krauel, MD PhD, role: CONTACT, phone: (+34) 932804000, phoneExt: 71263, email: marta.ramon@sjd.es, contacts name: Carles Lerin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False