[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597301":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":82,"studyPopulation":71,"armGroups":83,"interventions":96,"overallOfficials":108,"centralContacts":113,"locations":119,"responsibleParty":141,"collaborators":71,"id":144,"slug":71,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":71,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":71,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":167,"whyStopped":71,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"University of Guadalajara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":71},[9,13,16,19,22,25,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Waist Circumference (WC)","Waist Circumference (WC) is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest","Baseline to week 12 (end of intervention)",{"measure":14,"description":15,"timeFrame":12},"Systolic Blood Pressure (SBP)","Systolic Blood Pressure (SBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer",{"measure":17,"description":18,"timeFrame":12},"Diastolic Blood Pressure (DBP)","Diastolic Blood Pressure (DBP) is measured at baseline and after 12 weeks with a digital sphygmomanometer",{"measure":20,"description":21,"timeFrame":12},"High Density Lipoprotein Cholesterol (HDL-c)","High Density Lipoprotein Cholestero (HDL-c) is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":23,"description":24,"timeFrame":12},"Triglycerides (TG)","Triglycerides (TG) are evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":26,"description":27,"timeFrame":12},"Fasting Plasma Glucose (FPG)","Fasting Plasma Glucose (FPG) is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":29,"description":30,"timeFrame":12},"Insulin Sensitivity (IS)","Insulin Sensitivity (IS) will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity",{"measure":32,"description":33,"timeFrame":12},"Total Insulin Secretion (TIS)","Total Insulin Secretion (TIS) will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.",{"measure":35,"description":36,"timeFrame":12},"First Phase of Insulin Secretion (FPIS)","The First Phase if Insulin Secretion (FPIS) will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion",[38,41,44,47,50,53,56,59,62,65,68],{"measure":39,"description":40,"timeFrame":12},"Body Weight (BW)","Body Weight (BW) is evaluated at baseline and after 12 weeks with an inbody 270",{"measure":42,"description":43,"timeFrame":12},"Body Mass Index (BMI)","Body Mass Index (BMI) is calculated at baseline and after 12 weeks with the Quetelet index formula",{"measure":45,"description":46,"timeFrame":12},"Body Fat Percentage (BF%)","Body Fat Percentage (BF%) will be measured at baseline and week 12 with a bioimpedance analysis",{"measure":48,"description":49,"timeFrame":12},"Total Cholesterol (TC)","Total Cholesterol (TC) is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":51,"description":52,"timeFrame":12},"Low Density Lipoprotein Cholesterol (LDL-c)","Low Density Lipoprotein Cholesterol (LDL-c) level will be calculated at baseline and week 12 with Friedewald formula to get LDL-c level",{"measure":54,"description":55,"timeFrame":12},"Very Low Density Lipoprotein (VLDL)","Very Low Density Lipoprotein (VLDL) is calculated at baseline and after 12 weeks as triglycerides\u002F5",{"measure":57,"description":58,"timeFrame":12},"Aspartate Aminotransferase (AST)","Aspartate Aminotransferase (AST) is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":60,"description":61,"timeFrame":12},"Alanine Aminotransferase (ALT)","Alanine Aminotransferase (ALT) is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":63,"description":64,"timeFrame":12},"Creatinine","Creatinine is evaluated at baseline and after 12 weeks with enzymatic\u002Fcolorimetric techniques",{"measure":66,"description":67,"timeFrame":12},"Uric Acid (UA)","Uric Acid (UA) is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques",{"measure":69,"description":70,"timeFrame":12},"Adverse Events (AE)","Adverse Events (AE) of fenugreek seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":75,"primaryPurpose":76,"observationalModel":71,"timePerspective":71,"maskingInfo":77},"RANDOMIZED","PARALLEL","A randomized, double-blind, placebo-controlled clinical trial","TREATMENT",{"masking":78,"maskingDescription":71,"whoMasked":79},"DOUBLE",[80,81],"PARTICIPANT","INVESTIGATOR","A randomized, double-blind, placebo controlled clinical trial will be conducted in 28 patients with metabolic syndrome according to the criteria of the International Diabetes Federation. Patients will be assigned to two different arms: one group will receive fenugreek seed extract (1500 mg\u002Fday) or a matched placebo for 12 weeks.\n\nAt the beginning and end of the intervention, the following measurements will be taken: body weight, body mass index, waist circumference, body fat percentage, systolic blood pressure, diastolic blood pressure, glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein, insulin, creatinine, uric acid, alanine aminotransferase, and aspartate aminotransferase. In addition, insulin sensitivity and insulin secretion will be calculated. Written informed consent will be obtained from all volunteers.",[84,90],{"label":85,"type":86,"description":87,"interventionNames":88},"Fenugreek seed","EXPERIMENTAL","500 mg of fenugreek seed before each meal for 12 weeks",[89],"Dietary Supplement: Fenugreek seed",{"label":91,"type":92,"description":93,"interventionNames":94},"Placebo","PLACEBO_COMPARATOR","500 mg of calcined magnesia before each meal for 12 weeks",[95],"Other: Placebo",[97,103],{"type":98,"name":85,"description":99,"armGroupLabels":100,"otherNames":101},"DIETARY_SUPPLEMENT","Fenugreek seed: 1500 mg per day for 12 weeks",[85],[102],"Trigonella foenum-graecum",{"type":6,"name":91,"description":104,"armGroupLabels":105,"otherNames":106},"Placebo: Calcined magnesia 1500 mg per day for 12 weeks",[91],[107],"Calcined magnesia",[109],{"name":110,"affiliation":111,"role":112},"Marisol Cortez Navarrete, PhD","Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara","PRINCIPAL_INVESTIGATOR",[114],{"name":110,"role":115,"phone":116,"phoneExt":117,"email":118},"CONTACT","(33) 1058-5200","34211","marisol.cortez@academicos.udg.mx",[120],{"facility":121,"status":71,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"Instituto de Terapéutica Experimental y Clínica (INTEC), Centro Universitario de Ciencias de la Salud (CUCS), Universidad de Guadalajara.","Guadalajara","Jalisco","44340","Mexico","MX",{"type":128,"coordinates":129},"Point",[130,131],-103.34749,20.67738,{"lat":131,"lon":130},[134,136,140],{"name":110,"role":115,"phone":135,"phoneExt":117,"email":118},"3310585200",{"name":137,"role":115,"phone":135,"phoneExt":138,"email":139},"Karina G Pérez Rubio, PhD","34212","karina.prubio@academicos.udg.mx",{"name":110,"role":112,"phone":71,"phoneExt":71,"email":71},{"type":112,"investigatorFullName":142,"investigatorTitle":143,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"Marisol Cortez Navarrete","Principal investigator","100597301",false,"NCT07056712","Effect of Fenugreek Seed Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion","Effect of Fenugreek Seed Administration on the Components of Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion","Inclusion Criteria:\n\n* Men and women between 30 and 60 years old.\n* Diagnosis of Metabolic Syndrome (MS) according to the International Diabetes Federation (IDF) criteria.\n\nWaist circumference ≥90 cm in men and ≥80 cm in women, plus the presence of two or more of the following criteria:\n\n* Fasting glucose ≥100 mg\u002FdL or previous diagnosis of type 2 diabetes.\n* Systolic Blood Pressure ≥130 mmHg.\n* Diastolic Blood Pressure ≥85 mmHg.\n* Triglycerides ≥150 mg\u002FdL.\n* HDL cholesterol \\\u003C40 mg\u002FdL in men and \\\u003C50 mg\u002FdL in women.\n\n  * Body Mass Index between 25.0 and 34.9 kg\u002Fm².\n  * Stable weight during the 3 months prior to the start of the study (weight variation less than 10%).\n  * Not receiving pharmacological treatment for any component of MS, insulin sensitivity, and\u002For insulin secretion.\n  * Signed informed consent form.\n\nNon-Inclusion Criteria:\n\n* Suspected or confirmed pregnancy.\n* Breastfeeding period.\n* Fasting glucose ≥126 mg\u002FdL.\n* LDL cholesterol ≥155 mg\u002FdL.\n* Triglycerides ≥500 mg\u002FdL.\n* Systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg.\n* Use of medications and\u002For supplements known to influence the study variables.\n* History of kidney, thyroid, liver disease, or ischemic heart disease.\n* Active smoker.\n* Not using an effective and stable contraceptive method.\n\nExclusion Criteria:\n\n* Voluntary withdrawal of informed consent.\n* Treatment adherence ≤80%.\n* Occurrence of a serious adverse event.\n* Loss to follow-up.","ALL","30 Years","60 Years",{"count":154,"type":155},28,"ESTIMATED","INTERVENTIONAL",[158],"NA","Fenugreek has been shown to have beneficial effects on various metabolic abnormalities associated with metabolic syndrome (MS). However, no clinical trials have evaluated its effect on all components of MS, insulin sensitivity, and insulin secretion. Therefore, the main objective of this study is to assess the effect of fenugreek seed administration versus placebo on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.",[161],"Metabolic Syndrome",[161,163,164,165,166],"Fenugreek","Insulin Secretion","Insulin Sensitivity","Nutraceutic","NOT_YET_RECRUITING","2025-09-01",{"date":170,"type":171},"2025-09-08","ACTUAL",{"date":173,"type":155},"2025-09-15",{"date":175,"type":155},"2026-09-15",{"name":5,"class":6},1]