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