[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497676":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":66,"collaborators":69,"id":72,"slug":24,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Time-restricted feeding","EXPERIMENTAL","Subjects will follow a daily time-restricted feeding regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery.",[13],"Behavioral: Time-restricted feeding",{"label":15,"type":16,"description":17,"interventionNames":18},"Carbohydrate loading","ACTIVE_COMPARATOR","Subjects will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia",[19],"Dietary Supplement: Carbohydrate loading",{"label":21,"type":22,"description":23,"interventionNames":24},"Control group","NO_INTERVENTION","Subjects will continue their usual diet and proceed with standard preoperative fasting (i.e., eat up until 6 hours and take clear liquids up until 2 hours before induction of anaesthesia).",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"BEHAVIORAL","Subjects in the will be instructed to follow a TRF regimen consisting of a daily 8h ad libitum eating period and 16h water fasting period during the last 2 weeks before surgery. Participants will be encouraged to begin their eating period at 08:00h and end it at 16:00h, since the metabolic benefits of TRF appear to be considerably more pronounced when the eating period starts early in the day.",[9],{"type":31,"name":15,"description":32,"armGroupLabels":33,"otherNames":24},"DIETARY_SUPPLEMENT","Subjects will continue their usual diet and will receive two quantities of a clear beverage containing 12.5 g\u002F100 mL maltodextrin (50 kCal\u002F100 mL, pH 5.0); 800 mL at 22.00h on the evening before surgery and 400 mL two hours before anaesthesia induction.",[15],[35],{"name":36,"affiliation":37,"role":38},"Jeroen Hermanides, MSc","Amsterdam UMC, location AMC","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"A. Stobbe, MSc","CONTACT","+31205669111","a.y.stobbe@amsterdamumc.nl",{"name":46,"role":42,"phone":43,"phoneExt":24,"email":47},"Benedikt Preckel, MSc","b.preckel@amsterdamumc.nl",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Amsterdam UMC location AMC","RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands",{"type":57,"coordinates":58},"Point",[59,60],4.88969,52.37403,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":43,"phoneExt":24,"email":65},"R. van Wilpe, MSc","r.vanwilpe@amsterdamumc.nl",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":37,"oldNameTitle":24,"oldOrganization":24},"B Preckel","Prof. dr.",[70],{"name":71,"class":6},"European Society of Anaesthesiology and Intensive Care","100497676",false,"NCT05760339","Intermittent Fasting Versus Carbohydrate Drinks Before Surgery","Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial","PRINCESS","Inclusion Criteria:\n\n* Undergoing elective orthopaedic surgery;\n* Intermediate, major or complex surgery according to the Surgical Outcome Risk Tool (SORT; http:\u002F\u002Fwww.sortsurgery.com\u002F) severity of surgery classification;\n* Scheduled for surgery at least 17 days from the date of screening;\n* Motivated to follow a time restricted feeding regimen.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* History of diabetes mellitus;\n* History of feeding or eating disorders;\n* History of delayed gastric emptying or gastro-oesophageal reflux\n* Active malignancy\n* Patients classified as ASA IV by the attending anaesthetist;\n* BMI \\\u003C 18.5 or ≥ 35;\n* Outpatient or day case surgery;\n* Palliative surgery;\n* Participation in another clinical trial that is interfering with the procedures or outcomes of the PRINCESS trial;\n* Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch).","ALL","18 Years",{"count":82,"type":83},75,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.",[89,90,91,92,93,94],"Perioperative Care","Intermittent Fasting","Carbohydrate Loading","Preoperative Fasting","Orthopedic Surgery","Insulin Resistance",[89,91,93,94,96,97],"HOMA-IR","Time Restricted Feeding","2024-10-18",{"date":100,"type":101},"2024-10-22","ACTUAL",{"date":103,"type":101},"2023-03-20",{"date":105,"type":83},"2025-09",{"name":5,"class":6},1]