[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625312":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":52,"studyPopulation":41,"armGroups":53,"interventions":66,"overallOfficials":41,"centralContacts":78,"locations":85,"responsibleParty":100,"collaborators":41,"id":103,"slug":41,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":41,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":88,"whyStopped":41,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Universidad Católica San Antonio de Murcia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Glycated Hemoglobin (HbA1c)","Fasting glycated hemoglobin (HbA1c) will be measured in venous blood samples to assess long-term glycemic control.","Measurements will be performed at baseline, Day 45, and Day 90",{"measure":14,"description":15,"timeFrame":16},"Area Under the Curve (AUC) of Blood Glucose During Oral Glucose Tolerance Test","The area under the curve (AUC) of blood glucose will be calculated during an oral glucose tolerance test (OGTT) using a 50-g glucose load. Capillary blood glucose levels will be measured at 0, 15, 30, 45, 60, 90, and 120 minutes after glucose ingestion.","This assessment will be conducted at baseline, Day 45, and Day 90.",[18,22,26,30,33,37],{"measure":19,"description":20,"timeFrame":21},"Fasting and Post-Load Insulinemia","Fasting venous insulin levels will be measured at baseline. Post-load venous insulin concentrations will be determined at 45 and 90 minutes during the oral glucose tolerance test (50-g glucose load).","These measurements will be performed at baseline, Day 45, and Day 90.",{"measure":23,"description":24,"timeFrame":25},"Insulin Resistance","Peripheral insulin resistance will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)","They will be calculated at the start of the study, on day 45, and on day 90.",{"measure":27,"description":28,"timeFrame":29},"Insulin Sensitivity","Insulin sensitivity will be assessed using validated surrogate indices derived from fasting glucose and insulin levels: QUICKI (Quantitative Insulin Sensitivity Check Index).","It will be calculated at the start of the study, on day 45, and on day 90.",{"measure":31,"description":32,"timeFrame":21},"Body Composition Analysis","Body composition will be assessed using bioelectrical impedance analysis (BIA), providing estimates of fat mass, lean mass, and total body water.",{"measure":34,"description":35,"timeFrame":36},"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)","These measurements will be performed at baseline, on day 45, and on day 90.",{"measure":38,"description":39,"timeFrame":40},"Adverse events","It will be evaluated at each of the visits.","At 12 weeks after consumption",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Controlled, randomized, double-blind clinical trial with two parallel study arms based on the product consumed (placebo or nutritional product containing carob extract) and conducted at a single center.","PREVENTION",{"masking":48,"maskingDescription":49,"whoMasked":50},"SINGLE","Double-blind study. The organoleptic characteristics of the experimental product and the placebo will be identical.",[51],"INVESTIGATOR","This study evaluates the effects of NUTIFOOD (liquid nutritional product with carob extract) on insulin sensitivity and carbohydrate metabolism in subjects with abnormal glucose or HbA1c levels not on antidiabetic medication, over 90 days.\n\nKey assessments include: Glucose response (AUC and peak levels) during an oral glucose tolerance test. Changes in fasting glucose, HbA1c, and basal insulin. Insulin resistance measured by HOMA-IR and QUICKI. Effects on body composition. Safety and tolerability of the product.\n\nThe study aims to determine the potential of NUTIFOOD as a nutritional intervention to improve glucose regulation and metabolic health.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Carob liquid - GippsNature","EXPERIMENTAL","Participants will consume two daily doses of the experimental product (liquid carob extract) for 90 days.",[59],"Dietary Supplement: Experimental Product",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo","PLACEBO_COMPARATOR","Participants will consume two daily doses of a placebo product with the same organoleptic characteristics as the experimental product for 90 days.",[65],"Dietary Supplement: Control product",[67,73],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DIETARY_SUPPLEMENT","Experimental Product","Participants will consume two doses per day. The product should be taken 30 minutes before the two main meals of the day.",[55],[55],{"type":68,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Control product","Participants will consume two daily doses of the placebo product. The product should be taken 30 minutes before the two main meals of the day.",[61],[61],[79],{"name":80,"role":81,"phone":82,"phoneExt":83,"email":84},"Francisco Javier López Román","CONTACT","968278157","157","jlroman@ucam.edu",[86],{"facility":87,"status":88,"city":89,"state":41,"zip":41,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"UCAM HiTech, Sport & Health Innovation Hub","RECRUITING","Murcia","Spain","ES",{"type":93,"coordinates":94},"Point",[95,96],-1.13004,37.98704,{"lat":96,"lon":95},[99],{"name":80,"role":81,"phone":82,"phoneExt":83,"email":84},{"type":101,"investigatorFullName":80,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100625312",false,"NCT07420998","Effect of a Nutritional Product Containing Carob Extract on Carbohydrate Metabolism in Glucose-intolerant Subjects","Randomized Clinical Trial on the Effect of a Nutritional Product Containing Carob Extract (NUTIFOOD) on Carbohydrate Metabolism in Glucose-intolerant Subjects","NUTIFOOD","Inclusion Criteria:\n\n* Subjects of both sexes aged 18-65 years.\n* Diagnosis of glucose intolerance according to the American Diabetes Association (at least one of the following criteria):\n* Impaired fasting glucose (100-125 mg\u002Fdl)\n* Impaired glucose tolerance (oral glucose tolerance test with 2-hour plasma glucose between 140-199 mg\u002Fdl)\n* Glycated hemoglobin between 5.7% and 6.4%\n* Body mass index between 20-35 kg\u002Fm².\n* Stable dietary habits: no weight gain or loss greater than 5 kg in the last ten weeks.\n* Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.\n\nExclusion Criteria:\n\n* Use of medications that may interfere with glucose metabolism.\n* Subjects with a history of any type of hepatic or renal disease.\n* Alcohol consumption greater than 20 g\u002Fday.\n* History of allergic hypersensitivity or poor tolerance to any component of the study products.\n* Participation in another clinical trial within the three months prior to the study.\n* Lack of willingness or inability to comply with clinical trial procedures.\n* Pregnant or breastfeeding women.",true,"ALL","18 Years","65 Years",{"count":115,"type":116},30,"ESTIMATED","INTERVENTIONAL",[119],"NA","Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.",[122],"Prediabetes",[124,125,126,122],"Glucose","Insulin","Carob","2026-02-16",{"date":129,"type":130},"2026-02-19","ACTUAL",{"date":132,"type":130},"2026-01-26",{"date":134,"type":116},"2026-07",{"name":5,"class":6},1]