[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632922":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":90,"studyPopulation":80,"armGroups":91,"interventions":108,"overallOfficials":80,"centralContacts":117,"locations":123,"responsibleParty":137,"collaborators":80,"id":141,"slug":80,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":80,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":126,"whyStopped":80,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Universidad Católica San Antonio de Murcia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":80},[9],{"measure":10,"description":11,"timeFrame":12},"Weight","Evaluate the effects of chronic supplementation with two doses (600 and 300mg) of Xanthigen® on weight loss. Body weight refers to the measurement of a person's total mass in kilograms. It is a basic variable that indicates the amount of mass a person has in their body.\n\nIt will be assessed using the TANITA.","It will be measured at the beginning and at least once during the 4 months of consumption.",[14,17,20,24,27,31,34,38,41,44,48,51,54,57,61,65,68,71,74,77],{"measure":15,"description":16,"timeFrame":12},"Body mass index","It is calculated by dividing weight in kilograms by the square of height in meters.",{"measure":18,"description":19,"timeFrame":12},"Waist and hip circumference","Waist circumference refers to the measurement around the narrowest part of the abdominal area, and hip circumference is measured around the most prominent region of the buttocks",{"measure":21,"description":22,"timeFrame":23},"Visceral Adiposity Index (VAI)","The VAI is an index that combines waist circumference, hip circumference, body mass index, and blood triglyceride levels. It provides an estimate of visceral adiposity, which is the fat stored around the internal organs in the abdominal cavity.","From the beginning to 16 weeks",{"measure":25,"description":26,"timeFrame":12},"Fat mass","It will be measured using dual-energy X-ray absorptiometry (DEXA), which provides an accurate estimate of body composition.",{"measure":28,"description":29,"timeFrame":30},"Changes in body composition","Determine variations in body composition (lean mass and fat mass).","From the begynning to 16 weeks",{"measure":32,"description":33,"timeFrame":23},"Resting energy expenditure (REE)","Analyze the effect of Xanthigen® supplementation on resting energy expenditure (REE) and its possible significant increase after the intervention.",{"measure":35,"description":36,"timeFrame":37},"Blood pressure","It is measured in millimeters of mercury (mm Hg) and recorded as two values: systolic pressure (the pressure when the heart contracts) and diastolic pressure (the pressure when the heart is at rest between beats).","It will be evaluated from the start until 16 weeks of consumption.",{"measure":39,"description":40,"timeFrame":30},"Serum lipid profile","Assess the effect of the supplement on the lipid profile (total cholesterol, triglycerides, LDL, and HDL).",{"measure":42,"description":43,"timeFrame":30},"Effect on glucose metabolism","Analyze the effect of the intervention on glucose metabolism, including fasting glucose and insulin levels and glycosylated hemoglobin (HbA1c).",{"measure":45,"description":46,"timeFrame":47},"Plasma ghrelin concentration","Known as the \"hunger hormone.\" It will be evaluated through a blood sample. The unit of measurement will be pg\u002FmL","It will be measured at the beginning and after 4 months of consumption.",{"measure":49,"description":50,"timeFrame":47},"Plasma leptin concentration","Called the \"satiety hormone.\" It will be evaluated through a blood sample. The unit of measurement will be ng\u002FmL",{"measure":52,"description":53,"timeFrame":47},"Plasma adiponectin concentration","A hormone also produced by adipose tissue, but with effects opposite to what one would expect from an adipokine. It will be evaluated through a blood sample.\n\nThe unit of measurement will be µg\u002FmL",{"measure":55,"description":56,"timeFrame":47},"Superoxide dismutase (SOD)","Superoxide dismutase is an antioxidant enzyme that helps protect cells from oxidative damage. SOD levels can be used to assess oxidative stress in the body.",{"measure":58,"description":59,"timeFrame":60},"Serum metabolomic profile via metabolite analysis","A comprehensive and systematic study of the metabolites present in a serum sample will be conducted.","At 16 weeks after consumption",{"measure":62,"description":63,"timeFrame":64},"Psycological General Wellbeing Index (PGWBI)","The PGWBI is a measure of subjective psychological well-being. It assesses self-representations of intrapersonal affective or emotional states that reflect a sense of subjective well-being or ill-being and thus captures what we might call a subjective perception of well-being. It has a range of 0-110; higher scores indicate greater well-being","It will be measured at the beginning, after two months, and after four months of consumption.",{"measure":66,"description":67,"timeFrame":64},"Three factor eating questionnaire (TFEQ)","The TFEQ is a tool for assessing eating behavior. It measures three dimensions of human eating behavior: cognitive restriction of eating, disinhibition, and hunger.\n\nCognitive restriction, disinhibition, and hunger; range varies by subscale; higher scores indicate a greater presence of the behavior",{"measure":69,"description":70,"timeFrame":47},"24-hour dietary record","A 24-hour food record will be conducted to determine changes in participants' food intake. Estimated kcal\u002Fday will be recorded.",{"measure":72,"description":73,"timeFrame":47},"Physical Exercise Monitoring","The METs performed by the subjects will be evaluated to determine that there are no changes in the physical exercise performed.",{"measure":75,"description":76,"timeFrame":37},"Liver safety variables","It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI\u002FL).",{"measure":78,"description":79,"timeFrame":60},"Adverse events","It will be evaluated at each of the visits.",null,{"allocation":82,"interventionModel":83,"interventionModelDescription":80,"primaryPurpose":6,"observationalModel":80,"timePerspective":80,"maskingInfo":84},"RANDOMIZED","PARALLEL",{"masking":85,"maskingDescription":80,"whoMasked":86},"TRIPLE",[87,88,89],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Participants who meet the inclusion criteria will be included in the study. They will be randomized into three groups, each receiving a dose of the experimental product: 0mg (placebo), 300mg, or 600mg for 16 weeks. The treatment will be administered as a single daily dose in the morning on an empty stomach.\n\nAll participants will undergo the same assessments as the active-treatment groups, including anthropometric measurements, physical activity monitoring, and blood tests to evaluate metabolic and biochemical variables. Participants will be asked to maintain their usual dietary and physical activity habits throughout the study.",[92,98,104],{"label":93,"type":94,"description":95,"interventionNames":96},"Placebo Control Group","PLACEBO_COMPARATOR","Participants in this arm will receive a placebo identical in appearance and administration schedule to the active product. The treatment will be administered once daily in the morning on an empty stomach.",[97],"Dietary Supplement: Control product",{"label":99,"type":100,"description":101,"interventionNames":102},"Xanthigen® 300 mg Group","EXPERIMENTAL","Participants assigned to this arm will receive 300 mg of Xanthigen®, administered once daily in the morning on an empty stomach according to the study protocol.",[103],"Dietary Supplement: Experimental group: Xanthigen®",{"label":105,"type":100,"description":106,"interventionNames":107},"Xanthigen® 600 mg Group","Participants in this arm will receive 600 mg of Xanthigen®, administered once daily in the morning on an empty stomach.",[103],[109,114],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":80},"DIETARY_SUPPLEMENT","Experimental group: Xanthigen®","They will take one capsule per day.",[99,105],{"type":110,"name":115,"description":112,"armGroupLabels":116,"otherNames":80},"Control product",[93],[118],{"name":119,"role":120,"phone":121,"phoneExt":80,"email":122},"Francisco Javier López Román, Medical degree","CONTACT","+157 968278157","jlroman@ucam.edu",[124],{"facility":125,"status":126,"city":127,"state":127,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":80},"UCAM HiTech, Sport & Health Innovation Hub","RECRUITING","Murcia","30150","Spain","ES",{"type":132,"coordinates":133},"Point",[134,135],-1.13004,37.98704,{"lat":135,"lon":134},{"type":138,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":80,"oldOrganization":80},"PRINCIPAL_INVESTIGATOR","Francisco Javier López Román","Principal Investigator","100632922",false,"NCT07519980","Xanthigen and Its Impact on Weight and Metabolic Health","Effects of Xanthigen on Weight Control and Metabolic Variables in Overweight Individuals","XAN","Inclusion Criteria:\n\n* The subject is able and willing to follow the study protocol procedures to sign the informed consent form prior to the evaluations.\n* Participants must be between 20 and 50 years of age at the time of consent.\n* The subject is in good physical and mental health as determined by medical history, physical examination, electrocardiogram, vital signs, biochemistry, and hematology results.\n* Participants must have a BMI between 27 and 29.9 kg\u002Fcm2.\n* Desire to lose weight.\n\nExclusion Criteria:\n\n* Relevant medical history or presence of any medical condition that could interfere with this study, such as a previous diagnosis of diabetes, hypertension, hyperlipidemia, cardiovascular disease, thyroid disease, asthma, arthritis, or inflammatory conditions.\n* Fasting blood sugar levels greater than 125 mg\u002FdL and\u002For total cholesterol levels greater than or equal to 240 mg\u002FdL.\n* Blood pressure levels below 90\u002F140 mm Hg (diastolic\u002Fsystolic).\n* Chronic intake of medications\u002Fdietary supplements with an impact on body weight or body composition or lipid-modifying products (e.g., protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to selection or during the study.\n* Known allergy\u002Fsensitivity to any of the components of the investigational product.\n* Change in hormonal contraception or any use of hormone replacement therapy (HRT) during or at least 3 months prior to the study (if female).\n* Women of childbearing age who are pregnant or intend to become pregnant during the study period.\n* Use of any dietary supplements (except mineral supplements, e.g., Ca, Mg).\n* Participation in any weight loss intervention or recent change in body weight \\> 4.5 kg during the last 9 months.\n* History and\u002For presence of eating disorders such as bulimia, anorexia nervosa, or binge eating, as determined by the investigator.\n* Consumption of any dietary supplements (except mineral supplements, e.g., Ca, Mg).\n* Participation in any weight loss program or recent change in body weight \\> 4.5 kg during the last 9 months.\n* History and\u002For presence of eating disorders such as bulimia, anorexia nervosa, binge eating, as determined by the investigator.\n* Individuals who currently participate in aerobic exercise more than 4 times per week, or more than 2.5 hours per week.\n* Vegan lifestyle.\n* Current smoker or user of nicotine products or cessation of smoking within 1 year of the screening date.\n* Gastrointestinal diseases\u002Fconditions (colitis ulcers, Crohn's disease, peptic ulcers, celiac disease).",true,"ALL","20 Years","50 Years",{"count":153,"type":154},180,"ESTIMATED","INTERVENTIONAL",[157],"NA","Randomized, controlled, triple-blind clinical trial with three parallel arms based on the product consumed (low-dose experimental product, high-dose experimental product, and placebo product) and conducted at a single center to measure the efficacy of a product (Xanthigen®) on overweight or obesity during 16 weeks of consumption.",[160],"Obesity & Overweight",[162,163],"Obesity","Overweight","2026-05-03",{"date":166,"type":167},"2026-05-07","ACTUAL",{"date":169,"type":167},"2026-02-02",{"date":171,"type":154},"2026-09-15",{"name":5,"class":6},1]