[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100113967":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":11,"locations":61,"responsibleParty":75,"collaborators":11,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":11,"overallStatus":97,"whyStopped":98,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Rottapharm Spain","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL",null,[13],"Drug: Ispaghula husk",{"label":15,"type":16,"description":11,"interventionNames":17},"2","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ispaghula husk","1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route.",[9],[26],"Plantaben",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Placebo","1 sachet of effervescent powder b.i.d. during 16 weeks, oral route.",[15],[32,36,40,43,46,49,52,55,58],{"name":33,"affiliation":34,"role":35},"Jordi Salas, MD, PhD","Hospital Universitari San Joan de Reus (Tarragona)","STUDY_CHAIR",{"name":37,"affiliation":38,"role":39},"Luis Peña, MD, PhD","Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria)","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Margarita Alonso, MD, PhD","Hospital Universitario de Valladolid",{"name":44,"affiliation":45,"role":39},"Sergio Pinillos, MD","Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona)",{"name":47,"affiliation":48,"role":39},"Joan Bel, MD, PhD","Hospital Universitari Germans Trias i Pujol ( Badalona)",{"name":50,"affiliation":51,"role":39},"Gloria Bueno, MD, PhD","Hosp. Clínico Universitario de Zaragoza",{"name":53,"affiliation":54,"role":39},"Rosaura Leis, MD, PhD","Hospital Clínico Univ. de Santiago de Compostela",{"name":56,"affiliation":57,"role":39},"Teresa Muñoz, MD, PhD","Hospital Univ. del Niño Jesús (Madrid)",{"name":59,"affiliation":60,"role":39},"Albert Feliu, MD PhD","Hospital Univ. San Joan de Reus (Tarragona)",[62],{"facility":63,"status":11,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":11},"Hospital Universitari San Joan de Reus","Reus","Tarragona","43201","Spain","ES",{"type":70,"coordinates":71},"Point",[72,73],1.10687,41.15612,{"lat":73,"lon":72},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":76,"oldOrganization":77},"Anna Anguera","Research Manager","100113967","phase-2-trial-to-evaluate-the-effect-of-plantago-ovata-husk-in-the-remission-of-metabolic-syndrome-in-children-and-adolescents-100113967",false,"NCT00748787","Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents","Multicenter, Double Blind, Randomized, Controlled With Placebo, to Evaluate the Effect of the Treatment With Plantago Ovata Husk in the Incidence of the Remission of Metabolic Syndrome in Children and Adolescents Between 10 to 16 Years Old.","Inclusion Criteria:\n\n* Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:\n\n  1. Waist circumference \\> or equal to percentile 90 according the age.\n  2. Presence of 2 or more of following factors: systolic blood pressure \\> or equal 130 mmHg or diastolic \\> or equal to 85 mmHg, or treated hypertension\n  3. Cholesterol HDL \\\u003C 1.03 mmol\u002Fl or treatment with drugs to increase cHDL\n  4. Glucose blood levels \\> 5.6 mmol\u002Fl or type II diabetes diagnosed treated or no.\n\nExclusion Criteria:\n\n* Loss of body weight \\> 3kg in the last 2 months\n* Waist circumference 10 cm higher of 90 percentile according to the age\n* Intake of fiber, aven supplements or phytosterols in the last 2 months\n* Glycosylate haemoglobin \\>7% in the time of inclusion\n* Systolic blood pressure \\> 145 mmHg or Diastolic blood pressure \\>95 mmHg.","ALL","10 Years","16 Years",{"count":89,"type":90},19,"ACTUAL","INTERVENTIONAL",[93],"PHASE2","The metabolic syndrome represents a constellation of risk factors associated to the abdominal obesity that includes insulin resistance, lipids alterations, high blood pressure etc. Several studies support the hypothesis that the intake of soluble fiber might have a positive effect in the improvement of such of these risk factors.\n\nSo that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission of metabolic syndrome in children between 10 to 16 years old.",[96],"Metabolic Syndrome","TERMINATED","It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.","2011-06-07",{"date":101,"type":102},"2011-06-08","ESTIMATED",{"date":104,"type":11},"2008-10",{"date":106,"type":90},"2010-06",{"name":5,"class":6},1]