[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605671":3},{"organization":4,"outcomesModule":7,"designInfo":219,"detailedDescription":231,"studyPopulation":218,"armGroups":232,"interventions":255,"overallOfficials":273,"centralContacts":295,"locations":304,"responsibleParty":321,"collaborators":218,"id":323,"slug":218,"hasResults":324,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":330,"sex":331,"minAge":332,"maxAge":333,"enrollmentInfo":334,"targetDuration":218,"studyType":337,"phases":338,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":306,"whyStopped":218,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},{"fullName":5,"class":6},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":218},[9],{"measure":10,"description":11,"timeFrame":12},"Body weight","Weight of participants will be measured by bioimpedance an densitometry and reported in kg","Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3",[14,18,21,24,27,30,33,36,39,43,46,49,52,55,58,61,64,67,70,73,76,79,83,86,89,92,95,98,101,104,107,110,113,116,119,122,125,128,131,134,137,140,143,146,149,152,155,158,161,164,167,170,173,176,179,182,185,188,191,194,197,200,203,206,210,214],{"measure":15,"description":16,"timeFrame":17},"Height","Height of participants will be measured by stadiometer and reported in cm.","Clinical Investigation Day 1",{"measure":19,"description":20,"timeFrame":12},"Body mass index","Body mass index will be calculated as follows: weight (kilograms)\u002F height (m)2",{"measure":22,"description":23,"timeFrame":12},"Waist circumference","Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.",{"measure":25,"description":26,"timeFrame":12},"Hip circumference","Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.",{"measure":28,"description":29,"timeFrame":12},"Neck circumference","Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.",{"measure":31,"description":32,"timeFrame":12},"Body fat mass","Body fat of participants will be analyzed by bioimpedance and densitometry and reported in percentage and kilograms.",{"measure":34,"description":35,"timeFrame":12},"Body lean mass","Body lean mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.",{"measure":37,"description":38,"timeFrame":12},"Body muscle mass","Body muscle mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.",{"measure":40,"description":41,"timeFrame":42},"Fat free mass","Fat free mass of participants will be analyzed by densitometry and reported in kilograms.","Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.",{"measure":44,"description":45,"timeFrame":12},"Visceral fat","Visceral fat of participants will be measured by bioimpedance an densitometry and reported in g.",{"measure":47,"description":48,"timeFrame":12},"Body water mass","Body water mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms and percentage.",{"measure":50,"description":51,"timeFrame":12},"Body bone mass","Body bone mass Body bone mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.",{"measure":53,"description":54,"timeFrame":12},"Systolic blood pressure","Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg",{"measure":56,"description":57,"timeFrame":12},"Diastolic blood pressure","Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg",{"measure":59,"description":60,"timeFrame":12},"Heart rate","Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in pulses\u002Fmin.",{"measure":62,"description":63,"timeFrame":12},"Total bone mineral density","Total bone mineral density of participants will be analyzed by densitometry and reported in g\u002Fcm2.",{"measure":65,"description":66,"timeFrame":42},"Bone mineral density L1-L4","Bone mineral density L1-L4 of participants will be analyzed by densitometry and reported in g\u002Fcm2.",{"measure":68,"description":69,"timeFrame":42},"Total bone mineral density femur","Total bone mineral density femur of participants will be analyzed by densitometry and reported in g\u002Fcm2.",{"measure":71,"description":72,"timeFrame":42},"Bone mineral density femur neck","Bone mineral density femur neck of participants will be analyzed by densitometry and reported in g\u002Fcm2.",{"measure":74,"description":75,"timeFrame":42},"Knee articular range","Knee articular range of participants will be measured using a goniometer and performing the chair test.",{"measure":77,"description":78,"timeFrame":42},"Grip strength","Grip strength of participants will be measured using a manual dynamometer and reported in kg.",{"measure":80,"description":81,"timeFrame":82},"Level of hunger","Hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value is 100 mm. A reduction in hunger scale means better outcome.","Clinical Investigation Day 1, Clinical Investigation Day 2",{"measure":84,"description":85,"timeFrame":82},"Level of fullness","Fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.",{"measure":87,"description":88,"timeFrame":82},"Level of satisfaction","Satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.",{"measure":90,"description":91,"timeFrame":82},"Want to eat something else","Want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.",{"measure":93,"description":94,"timeFrame":82},"Thirst","Thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.",{"measure":96,"description":97,"timeFrame":12},"Life quality","Life quality of participants will be evaluated by SF-36 questionnaire (36-Item Short Form Survey).",{"measure":99,"description":100,"timeFrame":12},"Depression","Depression will be evaluated using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.",{"measure":102,"description":103,"timeFrame":12},"Anxiety","Anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI), a 40-item self-report questionnaire that includes two subscales: State Anxiety (20 items) and Trait Anxiety (20 items). Each subscale yields scores ranging from 20 to 80, with higher scores indicating greater levels of anxiety.",{"measure":105,"description":106,"timeFrame":12},"Osteoarticular health","Osteoarticular health of participants will be measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), a 24-item self-report questionnaire that assesses pain (range 0-20), stiffness (range 0-8), and physical function (range 0-68). The total score ranges from 0 to 96, with higher scores indicating worse osteoarticular symptoms and functional impairment.",{"measure":108,"description":109,"timeFrame":12},"Physical activity","Physical activity will be evaluated using the Physical Activity Questionnaire of the Seguimiento Universidad de Navarra (SUN) cohort, which estimates total physical activity expressed in Metabolic Equivalent of Task hours per week (MET-h\u002Fweek). Higher values indicate greater levels of physical activity. Participants can also be classified into categories of low, moderate, or high physical activity according to standardized SUN cohort scoring procedures.",{"measure":111,"description":112,"timeFrame":12},"Gastrointestinal symptoms","Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.",{"measure":114,"description":115,"timeFrame":12},"Glucose concentration","Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg\u002FdL.",{"measure":117,"description":118,"timeFrame":12},"Insulin concentration","Blood insulin concentration will be analyzed after an overnight fast by ELISA kit and reported in μUI\u002Fml.",{"measure":120,"description":121,"timeFrame":12},"HOMA index (Homeostatic Model Assessment Index)","HOMA index will be calculated as follows: HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)= \\[fasting glucose (mmol\u002FL) x fasting insulin (μU\u002Fml)\\] \u002F 22.5.",{"measure":123,"description":124,"timeFrame":12},"Total cholesterol","Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg\u002FdL",{"measure":126,"description":127,"timeFrame":12},"HDL cholesterol","Blood HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg\u002FdL",{"measure":129,"description":130,"timeFrame":12},"LDL cholesterol","LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg\u002FdL.",{"measure":132,"description":133,"timeFrame":12},"Triglyceride concentration","Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg\u002FdL.",{"measure":135,"description":136,"timeFrame":12},"Alanine aminotransferase","Alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI\u002FL.",{"measure":138,"description":139,"timeFrame":12},"Aspartate aminotransferase","Aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI\u002FL.",{"measure":141,"description":142,"timeFrame":12},"Gamma-glutamyl transferase","Gamma-glutamyl transferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI\u002FL.",{"measure":144,"description":145,"timeFrame":12},"Fatty liver Index (FLI)","Fatty liver Index will be calculated as follows FLI = (e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745)\u002F (1 + e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745) × 100",{"measure":147,"description":148,"timeFrame":12},"Fructosamine concentration","Blood fructosamine concentration will be analyzed after an overnight fast by ELISA kit and reported in µg\u002FL.",{"measure":150,"description":151,"timeFrame":12},"Leptine","Blood leptine concentration will be analyzed after an overnight fast by ELISA kit and reported in ng\u002Fml",{"measure":153,"description":154,"timeFrame":12},"Adiponectin","Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng\u002Fml.",{"measure":156,"description":157,"timeFrame":12},"Homocysteine","Blood homocysteine concentration will be analyzed after an overnight fast by biochemical autoanalyzer and reported in μmol\u002FL.",{"measure":159,"description":160,"timeFrame":12},"MCP1 (Monocyte Chemoattractant Protein-1)","Blood MCP1 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg\u002Fml.",{"measure":162,"description":163,"timeFrame":12},"TNF-alpha (tumor necrosis factor alpha)","TNF-alpha will be analyzed after an overnight fast by ELISA kit and reported in pg\u002Fml.",{"measure":165,"description":166,"timeFrame":12},"Interleukin 6 (IL6)","Blood IL6 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg\u002Fml.",{"measure":168,"description":169,"timeFrame":12},"C Reactive protein (CRP)","Blood CRP concentration will be analyzed after an overnight fast by ELISA kit and reported in mg\u002FL",{"measure":171,"description":172,"timeFrame":12},"Blood glycated hemoglobin","Fasting blood glycated hemoglobin will be reported in percentage.",{"measure":174,"description":175,"timeFrame":12},"Plasma CTX-II levels (C-terminal telopeptide of type II collagen)","Plasma CTX-II levels will be analyzed after an overnight fast by ELISA kit and reported in ng\u002Fml",{"measure":177,"description":178,"timeFrame":42},"Plasma C2C levels (Cartilage Collagen Neoepitope)","Plasma C2C levels will be analyzed after an overnight fast by ELISA kit and reported in ng\u002Fml.",{"measure":180,"description":181,"timeFrame":42},"Plasma CP2 levels (type II procollagen carboxy-propeptide)","Plasma CP2 levels will be analyzed after an overnight fast by ELISA kit and reported in ng\u002Fml.",{"measure":183,"description":184,"timeFrame":12},"Albumin concentration","Albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg\u002Fdl.",{"measure":186,"description":187,"timeFrame":12},"Creatinine concentration","Creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg\u002Fdl.",{"measure":189,"description":190,"timeFrame":12},"Hydroxyproline","Urine hydroxyproline concentration will be analyzed after an overnight fast by colorimetry technique and reported in mg\u002Fml.",{"measure":192,"description":193,"timeFrame":12},"Blood untargeted metabolomics","Untargeted metabolites will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.",{"measure":195,"description":196,"timeFrame":12},"Urine untargeted metabolomics","Untargeted metabolomics will be expressed and analyzed in urine according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.",{"measure":198,"description":199,"timeFrame":12},"Lipidomic","Lipidomic will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.",{"measure":201,"description":202,"timeFrame":12},"Dietary Intake (Energy and Nutrients)","Dietary intake will be assessed using the Food Frequency Questionnaire (FFQ). Outcomes will include energy intake (kcal\u002Fday), macronutrient intake (g\u002Fday), and micronutrient intake (mg\u002Fday or µg\u002Fday).",{"measure":204,"description":205,"timeFrame":12},"Mediterranean Diet Adherence","Adherence to the Mediterranean dietary pattern will be evaluated using the Mediterranean Diet Adherence Questionnaire, with scores ranging from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean diet.",{"measure":207,"description":208,"timeFrame":209},"Snacking frequency","Snacking behavior will be recorded using a daily snacking record. Results will be expressed as number of snacks per day.","Clinical Investigation Day 1, Clinical Investigation Day 2, and Clinical Investigation Day 3",{"measure":211,"description":212,"timeFrame":213},"Adherence to bars consumption","Adherence will be assessed using the bars consumption record form.","Clinical Investigation Day 2 and Clinical Investigation Day 3",{"measure":215,"description":216,"timeFrame":217},"Acceptance of bars","Acceptance will be assessed using the acceptance consumption record form.","Clinical Investigation Day 3",null,{"allocation":220,"interventionModel":221,"interventionModelDescription":222,"primaryPurpose":223,"observationalModel":218,"timePerspective":218,"maskingInfo":224},"RANDOMIZED","PARALLEL","4 parallel groups, 12-week, randomized nutritional intervention","TREATMENT",{"masking":225,"maskingDescription":218,"whoMasked":226},"QUADRUPLE",[227,228,229,230],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Volunteers expressing interest in the study will undergo an initial eligibility assessment, either via telephone interview or by completing an online screening form (Google Form), to verify compliance with the primary inclusion criteria. Candidates meeting these criteria will be invited to attend an information and screening visit, during which the study procedures will be explained in detail and any questions addressed. Individuals who agree to participate will provide written informed consent and will be randomly allocated to one of the four intervention groups. All necessary study materials will be provided at this stage.\n\nParticipants will attend three scheduled clinical investigation visits: baseline (day 0), mid-intervention (week 8), and post-intervention (week 12). At each visit, anthropometric and body composition measurements will be performed, and blood pressure will be recorded. Biological samples, including blood, urine, and stool, will be collected. In addition, data regarding dietary intake, physical activity levels, sleep patterns, and gastrointestinal symptoms will be obtained through validated questionnaires.",[233,239,244,249],{"label":234,"type":235,"description":236,"interventionNames":237},"Experimental group 1","EXPERIMENTAL","Bars containing satiating compounds: formulation 1",[238],"Dietary Supplement: Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)",{"label":240,"type":235,"description":241,"interventionNames":242},"Experimental group 2","Bars containing satiating compounds: formulation 2",[243],"Dietary Supplement: Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)",{"label":245,"type":235,"description":246,"interventionNames":247},"Experimental group 3","Bars containing satiating compounds: formulation 3",[248],"Dietary Supplement: Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)",{"label":250,"type":251,"description":252,"interventionNames":253},"Placebo group","PLACEBO_COMPARATOR","Placebo bars",[254],"Dietary Supplement: Placebo Bar + Hypocaloric diet (10% energy restriction)",[256,261,265,269],{"type":257,"name":258,"description":259,"armGroupLabels":260,"otherNames":218},"DIETARY_SUPPLEMENT","Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)","Participants will consume three satiating compound-enriched bars (formulation 1) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.",[234],{"type":257,"name":262,"description":263,"armGroupLabels":264,"otherNames":218},"Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)","Participants will consume three satiating compound-enriched bars (formulation 2) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.",[240],{"type":257,"name":266,"description":267,"armGroupLabels":268,"otherNames":218},"Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)","Participants will consume three satiating compound-enriched bars (formulation 3) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.",[245],{"type":257,"name":270,"description":271,"armGroupLabels":272,"otherNames":218},"Placebo Bar + Hypocaloric diet (10% energy restriction)","Participants will consume three placebo bars daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.",[250],[274,278,281,283,285,287,289,291,293],{"name":275,"affiliation":276,"role":277},"María Ángeles Zulet, PhD","Center for Nutrition Research","PRINCIPAL_INVESTIGATOR",{"name":279,"affiliation":276,"role":280},"Fermín Milagro, PhD","STUDY_CHAIR",{"name":282,"affiliation":276,"role":280},"Idoia Ibero",{"name":284,"affiliation":276,"role":280},"María Hernández",{"name":286,"affiliation":276,"role":280},"Miguel López, PhD",{"name":288,"affiliation":276,"role":280},"Verónica Ciaurriz",{"name":290,"affiliation":276,"role":280},"Carlos J González, PhD",{"name":292,"affiliation":276,"role":280},"Salomé Pérez",{"name":294,"affiliation":276,"role":280},"Marián Pueyo",[296,301],{"name":275,"role":297,"phone":298,"phoneExt":299,"email":300},"CONTACT","+34948425600","806317","mazulet@unav.es",{"name":279,"role":297,"phone":298,"phoneExt":302,"email":303},"806553","fmilagro@unav.es",[305],{"facility":276,"status":306,"city":307,"state":308,"zip":309,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":317,"contacts":318},"RECRUITING","Pamplona","Navarre","31008","Spain","ES",{"type":313,"coordinates":314},"Point",[315,316],-1.64323,42.81687,{"lat":316,"lon":315},[319],{"name":275,"role":297,"phone":320,"phoneExt":299,"email":300},"948425600",{"type":322,"investigatorFullName":218,"investigatorTitle":218,"investigatorAffiliation":218,"oldNameTitle":218,"oldOrganization":218},"SPONSOR","100605671",false,"NCT07165548","Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity","Evaluation of the Effect of Supplementation With Satiating Compounds Integrated Into a Hypocaloric Diet on Weight and Cardiometabolic and Osteoarticular Health in Overweight\u002FObese Subjects","COGLUBOCO","Inclusion Criteria:\n\n* Volunteers of both sexes between the ages of 18 and 65 years old.\n* Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg\u002Fm2).\n* Physical examination and vital signs are normal or clinically irrelevant to the study.\n* Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation.\n* Individuals undergoing treatment for diabetes will be excluded.\n* Participants must be capable of understanding the study requirements, willing to provide written informed consent, and able to comply with all study procedures and timelines.\n* Body weight must have remained stable (±5%) during the three months preceding study initiation.\n\nExclusion Criteria:\n\n* Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.\n* High alcohol consumption, defined as \\>14 units per week for women and \\>20 units per week for men.\n* Pregnancy or lactation at the time of screening.\n* History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).\n* Diagnosis of arthritis.\n* History of any liver disease, with the exception of non-alcoholic fatty liver disease.\n* Diagnosis of any type of cancer, current cancer treatment, or history of cancer treatment within the past five years.\n* Known allergy or hypersensitivity to any component of the investigational product or to any food that could interfere with study participation and follow-up.\n* Presence of cognitive and\u002For psychological impairment that could affect study compliance.\n* Anticipated poor adherence or, in the opinion of the investigator, inability to comply with study procedures.\n* Engagement in night-shift work.\n* Current use of dietary supplements that may interfere with study outcomes (e.g., nutraceuticals containing compounds with potential weight loss effects).\n* Ongoing treatment for weight loss or diabetes.",true,"ALL","18 Years","65 Years",{"count":335,"type":336},144,"ESTIMATED","INTERVENTIONAL",[339],"NA","The main objective of this intervention study is to evaluate the effect of satiating protein and\u002For fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity.\n\nTo achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period.\n\nThe main questions to answer are:\n\n* Does the regular consumption of these protein and\u002For fiber bars help to lose weight?\n* Does the regular consumption of these protein and\u002For fiber bars help to improve the osteoarticular health?\n* Does the regular consumption of these protein and\u002For fiber bars help to improve the cardiometabolic health?\n\nThe specific objectives are focused on evaluating the effects of the intervention on the following parameters:\n\n* Weight and body composition.\n* Knee joint range of motion.\n* Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health.\n* Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health.\n* Changes in joint discomfort (improvement or worsening).\n* Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement.\n* Satiety-related variables assessed using a visual analog scale (VAS).\n* Urinary hydroxyproline and stool samples for metagenomic analysis.\n* Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires.\n\nTarget sample size is 144 subjects and participants will be allocated in four different groups:\n\n* Group 1 (n=36): hypocaloric diet + protein and fiber supplement.\n* Group 2 (n=36): hypocaloric diet + protein and fiber supplement.\n* Group 3 (n=36): hypocaloric diet + fiber supplement.\n* Group 4 \"Placebo group\" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.",[342,343],"Obesity","Overweight",[345,346,347,348,349,342,350,351,352,105,353],"Nutritional intervention","Dietary supplement","Protein bar","Fiber bar","Hypocaloric Diet","Weight loss","Satiety","Cardiometabolic health","Quality of life","2025-09-08",{"date":356,"type":357},"2025-09-10","ACTUAL",{"date":359,"type":357},"2025-08-20",{"date":361,"type":336},"2026-06-30",{"name":5,"class":6},1]