[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361879":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":74,"collaborators":30,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":30,"enrollmentInfo":85,"targetDuration":30,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic diet","EXPERIMENTAL","the intervention will consist of 3 phases: a two week run-in period, 12 weeks strict KD and 6 months Modified Atkins Diet.\n\nDuring the run-in period, patients will become familiar with their diet and, in particular, they will learn which foods are allowed and which are not. Ketogenic ratio wil build up to 3:1 - 4:1, ensuring protein needs.",[13],"Dietary Supplement: Ketogenic diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Isocaloric diet","ACTIVE_COMPARATOR","During the run-in period, the dietician will discuss the diet and maintenance of an isocaloric diet with the patients. As such, the diet of the control group will not change from their normal dietary pattern. In the latter case, the patient will be asked to change the diet to a normal Belgian diet, according to Flemisch dietary guidelines.",[19],"Dietary Supplement: Isocaloric diet",{"label":21,"type":10,"description":22,"interventionNames":23},"Ketone ester supplementation","Arm Description: the intervention will consist of 3 phases: a two week run-in period, 12 weeks strict of Ketone ester supplementation and 6 months of the follow-up with a healthy diet. Ke supplements will be ingested 3 times a day separately from a meal in fixed doses of 25g. If blood β-OHB levels are substantially below 3mmol\u002FL, a weight-based dosing of the KEs (up to 0.5g\u002Fkg bodyweight), rather than a fixed dosing strategy, will be utilized.",[24],"Dietary Supplement: Ketone ester supplementation",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Multivit and Metarelax. This multivitamin and Magnesium supplement will provide necessary vitamins and decrease ketone-flu sympotms, repsectively.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Patients will follow an isocaloric diet",[15],{"type":27,"name":21,"description":35,"armGroupLabels":36,"otherNames":30},"25g of a ketone monoester, ingested 3 times a day for a period of 12 weeks. Ingestion is separated from a meal and interspersed by at least 4 hours to ensure maximal available ketone bodies circulating in the blood.",[21],[38],{"name":39,"affiliation":40,"role":41},"Nicolas Timmermans, Msc","KU Leuven","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Sarah Thomis, MD","CONTACT","003216346948","sarah.thomis@uzleuven.be",{"name":49,"role":45,"phone":50,"phoneExt":30,"email":51},"Christoph Matthys, PhD","003216342655","christophe.matthys@uzleuven.be",[53],{"facility":54,"status":55,"city":56,"state":30,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"UZ Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":61,"coordinates":62},"Point",[63,64],4.70093,50.87959,{"lat":64,"lon":63},[67,68,72],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},{"name":69,"role":45,"phone":70,"phoneExt":30,"email":71},"Patricia Devrieze","003216341759","patricia.devrieze@uzleuven.be",{"name":39,"role":73,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"type":75,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100361879","nutritional-ketosis-a-novel-metabolic-strategy-to-treat-lymphedema-patients-100361879",false,"NCT03991897","Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?","KETOLYMPH","Inclusion Criteria:\n\n* \\>18 years;\n* unilateral lymphedema of the arm lymph node dissection\n* lymphedema onset less than a year before the therapy starts\n* lymphedema defined as \\>3% volume difference between both arms\n* lymphedema stage 1, stage 2a or stage 2b\n* absence of pregnancy at the time of enrollment and willingness to use adequate contraceptive measures until the end of the study;\n* oral and written approval of the informed consent presented at the time of the consultation by the physicians;\n* understanding Dutch\n\nExclusion Criteria:\n\n* \\\u003C18 years;\n* edema of the limb with different etiology or later stage\u002Fonset as specified in the inclusion criteria;\n* presence of active cancer\n* pregnancy or active breastfeeding;\n* impossibility to participate for the entire study period;\n* mentally or physically unable to participate to the study;\n* presence of gastrointestinal intolerance or other serious illness (e.g. renal failure, hepatic dysfunction, heart failure, neurological impairment);\n* presence of diabetes or other metabolic disease;\n* contra-indication for the use of indocyanine green (ICG): allergy to ICG or iodine, hyperthyroidism.","ALL","18 Years",{"count":86,"type":87},81,"ESTIMATED","INTERVENTIONAL",[90],"NA","Lymphedema is a debilitating disorder that severely impairs the quality of life of the patients and requires life-long attention. Treatment for lymphatic dysfunction remains largely symptomatic, without real cure. According to the International Society of Lymphology, lymphedema has to be treated with Decongestive Lymphatic Therapy.\n\nResearch in the lab of Angiogenesis and Vascular Metabolism (PCA lab) reported in mice that metabolism of endothelial cells controls vessel sprouting. Experiments showed that a ketogenic diet (KD) reduced the edema of the mice tail and enhanced the lymphatic transport. Based on these proof-of-concept data, the investigators plan to test this innovative concept to ameliorate lymph vessel dysfunction in lymphedema patients. Randomisation will be performed between a ketogenic diet and an isocaloric diet with and without ketone ester supplementation.",[93,94,95],"Lymphedema","Ketogenic Dieting","Ketone Ester Supplement",[97,98,99],"ketosis","lymphedema","dermal backflow","2025-11-25",{"date":102,"type":103},"2025-12-03","ACTUAL",{"date":105,"type":103},"2025-10-01",{"date":107,"type":87},"2028-08-01",{"name":5,"class":6},1]