protocolSection identificationModule nctId: NCT06377631, orgStudyIdInfo id: FATHIS+, briefTitle: Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity, acronym: FATHIS+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Fundació Eurecat, class: OTHER, collaborators name: Centre de Diagnosi per la Imatge, collaborators name: Instituto de Investigación Biomédica de Girona (IDIBGI), collaborators name: Laboratorio de Referencia de Cataluña, descriptionModule briefSummary: This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity., conditionsModule conditions: Visceral Obesity, conditions: Non-alcoholic Fatty Liver, conditions: Postmenopausal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Visceral Adiposity, secondaryOutcomes measure: Height (cm), secondaryOutcomes measure: Age, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Change in Body Weight (kg), secondaryOutcomes measure: Change in Body Mass Index (BMI) (Kg/m^2), secondaryOutcomes measure: Change in Neck circumference (cm), secondaryOutcomes measure: Change in Arm circumference (cm), secondaryOutcomes measure: Change in Waist circumference (cm), secondaryOutcomes measure: Change in Hip circumference (cm), secondaryOutcomes measure: Change in Conicity Index, secondaryOutcomes measure: Change in Waist-to-Hip ratio, secondaryOutcomes measure: Change in Lipid Accumulation Product (LAP), secondaryOutcomes measure: Change in Systolic Blood Pressure (mm Hg), secondaryOutcomes measure: Change in Diastolic Blood Pressure (mm Hg), secondaryOutcomes measure: Change in heart rate (bpm), secondaryOutcomes measure: Change in serum glucose levels (mg/dL), secondaryOutcomes measure: Change in serum total cholesterol (mg/dL), secondaryOutcomes measure: Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL), secondaryOutcomes measure: Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL), secondaryOutcomes measure: Change in serum triglycerides (TG, mg/dL), secondaryOutcomes measure: Change in serum alanine aminotransferase (ALT, U/L), secondaryOutcomes measure: Change in serum aspartate aminotransferase (AST, U/L), secondaryOutcomes measure: Change in serum gamma glutamyl transferase (GGT, U/L), secondaryOutcomes measure: Change in serum insulin levels (mU/L), secondaryOutcomes measure: Change in serum leptin levels (pg/mL), secondaryOutcomes measure: Change in serum adiponectin levels (ng/mL), secondaryOutcomes measure: Change in Adiponectin/Leptin ratio (numerical ratio), secondaryOutcomes measure: Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL), secondaryOutcomes measure: Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL), secondaryOutcomes measure: Change in plasma Interleukin 6 (IL-6) levels (pg/mL), secondaryOutcomes measure: Change in plasma Interleukin 10 (IL-10) levels (pg/mL), secondaryOutcomes measure: Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL), secondaryOutcomes measure: Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL), secondaryOutcomes measure: Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L), secondaryOutcomes measure: Change in serum C-Reactive protein levels (mg/L), secondaryOutcomes measure: Change in Histidine levels in blood (umol/L), secondaryOutcomes measure: Change in Acylcarnitine levels in blood (umol/L), secondaryOutcomes measure: Change in 17-beta-estradiol (E2) levels in blood (pg/mL), secondaryOutcomes measure: Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL), secondaryOutcomes measure: Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR), secondaryOutcomes measure: Change in Fatty Liver Index (FLI), secondaryOutcomes measure: Change in Triglyceride glucose index (TyG), secondaryOutcomes measure: Change in Plasma atherogenic index, secondaryOutcomes measure: Change in lipidomic profile, secondaryOutcomes measure: Change in intestinal microbiota composition, secondaryOutcomes measure: Change in the expression of lipid-metabolism genes in PBMC, secondaryOutcomes measure: Change in Dietary habits, secondaryOutcomes measure: Change in Physical activity, secondaryOutcomes measure: Concomitant medication, secondaryOutcomes measure: Consumption of dietary supplements, secondaryOutcomes measure: Change in the Supraclavicular skin temperature, secondaryOutcomes measure: Change in postmenopausal symptoms, secondaryOutcomes measure: Adverse events, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Crescenti, city: Reus, state: Catalonia. Spain, zip: 43204, country: Spain, contacts name: Anna Crescenti, PhD, role: CONTACT, phone: 977770958, email: anna.crescenti@eurecat.org, geoPoint lat: 41.15612, lon: 1.10687, hasResults: False