[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581452":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":59,"collaborators":41,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":41,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":41,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":41,"overallStatus":45,"whyStopped":41,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Maxima Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VLCD (Very-Low-Calorie-Diet)","ACTIVE_COMPARATOR","Patients in the VLCD group receive, as prescribed by a dietician, three meal sachets a day.\n\nEach meal contains ±240kcal (=1004 kJ), 17-20g carbohydrates and 14-17g proteins.\n\nAltogether, this diet contains less than 800 kcal\u002Fday, 50-60g carbohydrates per day and 42-51g protein per day. The diet is continued for 14 days, until the day prior to surgery. In addition to using liquid meals, patients are allowed to consume raw vegetables (e.g., endive, spinach, cucumber, lettuce; without oil or dressings), and clear soups. Patients are advised to drink at least two liters per day of mineral water, tea, infusions or coffee without milk and\u002For sugar.",[13],"Dietary Supplement: VLCD (Very-low-calorie-diet)",{"label":15,"type":10,"description":16,"interventionNames":17},"VLCKD (Very-Low-Calorie-Ketogenic-Diet)","Six meal sachets are given to patients in the VLCKD group each day. A single meal has 16-19g of proteins, 2-3g of carbohydrates, and ±86kcal (=363 kJ). Together, the daily energy intake from this diet is less than 800 kcal, 50 g of carbohydrates, and 100 g of proteins. The diet is followed up to the day before surgery for a total of 14 days. Patients are recommended to ingest vegetables with a low glycaemic load (such as sprouts, lettuce, spinach, and tomatoes) in addition to the liquid meals. Patients are encouraged to consume at least two liters of mineral water, tea, infusions, or coffee without milk or sugar each day.",[18],"Dietary Supplement: VLCKD (ketogenic diet)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","VLCKD (ketogenic diet)","diets prior to bariatric surgery",[15],[26],"VLCKD",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"VLCD (Very-low-calorie-diet)",[9],[31],"VLCD",[33],{"name":34,"affiliation":5,"role":35},"Francois van Dielen, MD PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Aliyar Esfandiyari Noushi, MD","CONTACT","+31408888550",null,"aliyar.esfandiyarinoushi@mmc.nl",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Veldhoven","North Brabant","5500MB","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],5.40278,51.41833,{"lat":55,"lon":54},[58],{"name":38,"role":39,"phone":41,"phoneExt":41,"email":41},{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Aliyar Esfandiyari Noushi","Doctor of Medicine","100581452","ketogenic-diet-prior-to-bariatric-surgery-100581452",false,"NCT06850493","Ketogenic Diet Prior to Bariatric Surgery","The Impact of a Preoperative Very Low Calorie Ketogenic Diet (VLCKD) on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial","Inclusion Criteria:\n\n* Eligible for bariatric surgery (≥35 kg\u002Fm2 with obesity-related comorbidities, or a BMI of\n\n  * 40 kg\u002Fm2 with or without comorbidities)\n* Roux-en-Y Gastric bypass (RYGB)\n\nExclusion Criteria:\n\n* Weighing over 150kg because this amount is a limitation by the DXA device\n* Diabetes mellitus type 1\n* Allergic to milk proteins\n* A recent history of a heart attack (\\\u003C 12 months), heart failure or cardiac arrhythmias\n* Kidney and\u002For liver failure (creatinine levels \\>1.3 mg\u002Fdl or liver enzyme levels (AST, ALT, GGT)) less than three times over the upper normal threshold\n* Current infectious, sepsis or malignant disease\n* Rare condition like galactosemia, phenylketonuria or porphyria\n* Persistent diarrhoea\n* Hypokalaemia, chronic therapies with diuretics as furosemide and hydrochlorothiazide\n* Pregnancy or plans to get pregnant in the coming months\n* Patients who did not meet criteria to be eligible for bariatric surgery (BMI \\\u003C35, psychological or unstable psychiatric disorders, inadequate dietary regimen or inadequate exercise pattern which can't be resolved in the upcoming 6 months)",true,"ALL","18 Years","65 Years",{"count":74,"type":75},46,"ESTIMATED","INTERVENTIONAL",[78],"NA","Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls.\n\nVery low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.",[81,82],"Bariatric Surgery Candidate","Ketogenic Dieting","2025-02-24",{"date":85,"type":86},"2025-02-27","ACTUAL",{"date":88,"type":86},"2022-09-01",{"date":90,"type":75},"2025-12",{"name":5,"class":6},1]