[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613045":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Primorska","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Crocus sativus","EXPERIMENTAL","Crocus sativus tepals cold aqueous extract",[13],"Biological: Crocus sativus tepals cold aqueous extract",{"label":15,"type":16,"description":17,"interventionNames":18},"water","SHAM_COMPARATOR","cold water",[19],"Biological: cold water",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","2 g of Crocus sativus tepals will be infused in 200 mL of water overnight at 4 °C, resulting cold aqueous extract corresponds to 40 mg GAE of polyphenols",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"200 mL of cold water, kept overnight at 4 °C",[15],[30],{"name":31,"affiliation":32,"role":33},"Nina Mohorko, PhD","University pf Primorska, Faculty of Health Sciences","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+386 5 66 35 818","nina.mohorko@fvz.upr.si",[40],{"facility":32,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Izola","6310","Slovenia","SI",{"type":47,"coordinates":48},"Point",[49,50],13.66015,45.53661,{"lat":50,"lon":49},[53,54,58,59,62,63,65],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Ana Petelin, PhD","+386 5 66 26 469","ana.petelin@fvz.upr.si",{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Zala Jenko Pražnikar, PhD","SUB_INVESTIGATOR",{"name":55,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":64,"role":61,"phone":25,"phoneExt":25,"email":25},"Bernarda Habe",{"name":66,"role":61,"phone":25,"phoneExt":25,"email":25},"Tanja Črešnovar",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Nina Mohorko","Associate professor",[71],{"name":72,"class":6},"Università Politecnica delle Marche","100613045","early-phase-1-crocus-sativus-tepals-water-extract-in-obesity-and-prediabetes-100613045",false,"NCT07261475","Crocus Sativus Tepals Water Extract in Obesity and Prediabetes","Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes","ZAFRAN","Inclusion Criteria:\n\n* Obesity type I (ITM \\> 30 kg\u002Fm2) and\u002For\n* Prediabetes (fasting glucose levels 6,1 - 6,9 mmol\u002FL)\n\nExclusion Criteria:\n\n* Gastrointestinal diseases\n* Diabetes mellitus of any type\n* Pregnant or lactating, without contraception\n* Serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases\n* Participation in another clinical trial 3 months prior to the study\n* ITM greater than 35 kg\u002Fm2\n* Celiac disease of gluten intolerance\n* electronic implant","ALL","40 Years","65 Years",{"count":85,"type":86},20,"ESTIMATED","INTERVENTIONAL",[89],"EARLY_PHASE1","The goal of this clinical trial is to determine the acute effects of ingestion of a cold aqueous extract of Crocus sativus tepals on postprandial glycemia and other indicators of metabolic health in patients with obesity and\u002For prediabetes. The main questions it aims to answer are:\n\n* Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal improve the glycemic response to a standard meal?\n* How does the ingestion of Crocus sativus tepals aqueous extract prior to a meal impact insulin levels and other markers of metabolic health?\n* Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal increase the resting energy expanditure?\n\nResearchers will compare Crocus sativus tepals cold aqueous extract to cold water.\n\nThe participants will visit the Faculty twice - on one visit they will ingest Crocus sativus tepals cold aqueous extract and on the other cold water (in random order) 5 minutes prior to a standard meal of 100 g of white bread.\n\nOn each visit, anthropometric measurements will be performed upon arrival. Blood samples will be collected 3 times, preceeded by resting metabolic rate and blood pressure measurements: at baseline in fasted conditions, and 60 minutes and 120 minutes after consuming the bread.\n\nThere will be an at least 7 days wash-out period between the two visits.",[92,93],"Prediabetes","Obesity & Overweight",[95,96,97,98,99,100],"Crocus sativus tepals","Glycaemia","Oral glucose tolerance test","resting metabolism","blood pressure","insulin","2026-02-03",{"date":103,"type":104},"2026-02-04","ACTUAL",{"date":106,"type":86},"2026-02-06",{"date":108,"type":86},"2026-12",{"name":5,"class":6},1]