[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100214313":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":24,"locations":45,"responsibleParty":68,"collaborators":71,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":24,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":99,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Fondazione Edmund Mach","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aleurone supplementation","EXPERIMENTAL","The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Aleurone\u002Fday. One bread bun (35 g) contains 4.8 g Aleurone; one biscuit (15 g) contains 4 g Aleurone; 36 g of RTE cereals contain 9 g Aleurone.",[13],"Dietary Supplement: Aleurone",{"label":15,"type":16,"description":17,"interventionNames":18},"Hemicellulose supplementation","PLACEBO_COMPARATOR","The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Hemicellulose\u002Fday. One bread bun (35 g) contains 4.8 g Hemicellulose; one biscuit (15 g) contains 4 g Hemicellulose; 36 g of RTE cereals contain 9 g Hemicellulose. Placebo products contain the same levels of cellulose in place of aleurone's dietary fiber content.",[19],"Dietary Supplement: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Aleurone",null,[9],[27],"Cargill R&D Centre Europe ASP-01 Aleurone",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Placebo",[15],[32],"Placebo hemicellulose",[34,37,41],{"name":35,"affiliation":5,"role":36},"Kieran M Tuohy, PhD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":40},"Carlo Pedrolli, MD","Azienda Sanitaria per i Servizi Sanitari della Provincia Autonoma di Trento","STUDY_DIRECTOR",{"name":42,"affiliation":43,"role":44},"Douwina Bosscher, PhD","Cargill FIS\u002F Global Food Research","STUDY_CHAIR",[46,59],{"facility":47,"status":24,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":24},"Fondazione Edmund Mach -Centro Ricerca ed Innovazione","San Michele all'Adige","TN","38010","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],11.13212,46.18967,{"lat":57,"lon":56},{"facility":60,"status":24,"city":61,"state":49,"zip":62,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":67,"contacts":24},"Unità di Dietetica e Nutrizione Clinica, Ospedale S. Chiara, Via Orsi 1","Trento","38100",{"type":54,"coordinates":64},[65,66],11.12108,46.06787,{"lat":66,"lon":65},{"type":36,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Francesca Fava","Dr",[72,75],{"name":73,"class":74},"Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium","UNKNOWN",{"name":76,"class":6},"Azienda Sanitaria Universitaria Integrata del Trentino","100214313","measuring-the-impact-of-dietary-supplementation-with-a-high-fiber-high-antioxidant-aleurone-on-biomarkers-of-cardiovascular-disease-and-gut-microbiota-in-adults-with-high-body-mass-index-100214313",false,"NCT02067026","Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index","Inclusion Criteria:\n\n* BMI above 30 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* fasting blood glucose \\>300 mg\u002Fdl;\n* triglycerides \\>500 mg\u002Fdl;\n* uncontrolled hypertension (BP \\>160\u002F100 mm Hg under antihypertensive therapy); cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, unstable angina pectoris, stoke, peripheral arterial disease);\n* hypo- or hyperthyroidism;\n* acute inflammatory diseases;\n* severe gastrointestinal diseases;\n* heart, liver, renal or pulmonary failure or other life threatening disease with prognosis \\\u003C5 years;\n* chronic use of systemic corticosteroids, anti-coagulants, anti-inflammatory, or lipid lowering and anti-diabetics drugs;\n* treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels or fecal microbiota (specifically, antibiotics);\n* food intolerances;\n* alcohol intake \\>5 drinks per day or use of narcotic substances;\n* use of antioxidant vitamin or mineral supplements;\n* special diet;\n* pregnancy;\n* smoking.",true,"ALL","18 Years","65 Years",{"count":88,"type":89},75,"ACTUAL","INTERVENTIONAL",[92],"NA","Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic risk profiles and gut microbiota in subjects with high BMI\n\nPrimary objectives of the trial are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile acid and fecal sterol concentrations.\n\nSecondary objectives are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal permeability in plasma; (8) inflammation\n\nStudy Design Placebo-controlled, randomized, double-blind parallel trial Criteria for Enrollment Inclusion criteria: Aged 18-65 years; BMI \\>27 kg\u002Fm\\^2. Good General health.\n\nExclusion criteria: Fasting blood glucose \\>300 mg\u002Fdl; triglycerides \\>500 mg\u002Fdl; uncontrolled hypertension (blood pressure \\[BP\\] \\>160\u002F100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake \\>5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking.\n\nMethodology After a run-in phase of two weeks, participants will be randomized to receive supplementation with either wheat Aleurone-rich food (27 g Aleurone\u002Fday) or placebo for 4 weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S. di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento. A 4 day-food diary record will be collected before visits T0 and T1.\n\nEfficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis.\n\nSafety Assessments. Adverse events.\n\nStatistical analyses. Post-intervention data will be compared by ANOVA using the General Linear Model with baseline as a covariate. Data with a skewed distribution will be log transformed before analyses. Simple and multiple linear regression will be used to determine relationships between variables and independent t-tests performed to evaluate differences in reported compliance between groups. Results will be expressed as mean +\u002F- SEM and differences will be considered significant at P \\\u003C 0.05..\n\nDuration of Dosing. Subjects will make three visits during the study (start of run-in phase - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is targeted.",[95,96],"Overweight","Healthy Subjects",[98],"overweight","COMPLETED","2015-08-11",{"date":102,"type":103},"2015-08-13","ESTIMATED",{"date":105,"type":24},"2014-01",{"date":107,"type":89},"2015-07",{"name":5,"class":6},2]