[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581615":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":16,"armGroups":30,"interventions":40,"overallOfficials":50,"centralContacts":55,"locations":60,"responsibleParty":91,"collaborators":93,"id":102,"slug":16,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":16,"enrollmentInfo":111,"targetDuration":16,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":63,"whyStopped":16,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Change in lactate during the dietary intervention compared to baseline under the usual diet","Lactate belongs to the parameters of secondary metabolic disturbance traditionally used to estimate metabolic control in GSDI in routine clinical practice (lactate, triglycerides, uric acid). Redundant measurements of lactate are performed in blood as well as in collected urine.","4 Weeks",[14,17,19,21],{"measure":15,"description":16,"timeFrame":12},"Change in plasma triglycerides during the dietary intervention compared to baseline (as parameters traditionally measured together with lactate to estimate overall metabolic control)",null,{"measure":18,"description":16,"timeFrame":12},"Change in plasma uric acid during the dietary intervention compared to baseline (as parameters traditionally measured together with lactate to estimate overall metabolic control)",{"measure":20,"description":16,"timeFrame":12},"Plasma metabolite changes in targeted metabolomics during the dietary intervention compared to baseline measurements.",{"measure":22,"description":16,"timeFrame":12},"Plasma metabolite changes in targeted lipidomics during the dietary intervention compared to baseline measurements.",{"allocation":24,"interventionModel":25,"interventionModelDescription":16,"primaryPurpose":26,"observationalModel":16,"timePerspective":16,"maskingInfo":27},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":28,"maskingDescription":16,"whoMasked":16},"NONE","To assess relaxed restriction of fructose and fructose\u002Fgalactose intake on secondary metabolic alterations in GSDI, (i) by looking at the traditional parameters for assessing metabolic control in clinical chemistry (lactate, triglycerides, uric acid), and (ii) by using a broad analytical approach relying on targeted metabolomics\u002Flipidomics.\n\nIt is hypothesized that relaxed restrictions on the intake of fructose and\u002For galactose as part of the diet in everyday life may lead to an increase in blood lactate levels (=primary outcome), triglycerides, and uric acid to a certain degree compared to baseline. However, this increase is expected to remain within a range that is not clinically relevant for adult patients, especially when fructose\u002Fgalactose intake is not excessive and stays within the usual daily allowances for healthy individuals, as planned in this study.",[31,36],{"label":32,"type":33,"description":16,"interventionNames":34},"Diet with additional fructose intake","EXPERIMENTAL",[35],"Dietary Supplement: Fructose",{"label":37,"type":33,"description":16,"interventionNames":38},"Diet with additional fructose and galactose intake",[39],"Dietary Supplement: Fructose and galactose",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":16},"DIETARY_SUPPLEMENT","Fructose","40g fructose (free and bound, max amount of fructose from added free sugar\u002Fsaccharose 25g)",[32],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":16},"Fructose and galactose","10g galactose (mostly from lactose) plus 40g of fructose (free and bound, max amount of fructose from added free sugar\u002Fsaccharose 25g)",[37],[51],{"name":52,"affiliation":53,"role":54},"Michel Hochuli, MD, PhD","Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism","PRINCIPAL_INVESTIGATOR",[56],{"name":52,"role":57,"phone":58,"phoneExt":16,"email":59},"CONTACT","+41 31 664 03 18","michel.hochuli@insel.ch",[61,76],{"facility":62,"status":63,"city":64,"state":16,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital","RECRUITING","Bern","3010","Switzerland","CH",{"type":69,"coordinates":70},"Point",[71,72],7.44744,46.94809,{"lat":72,"lon":71},[75],{"name":52,"role":57,"phone":16,"phoneExt":16,"email":16},{"facility":77,"status":78,"city":79,"state":16,"zip":80,"country":66,"countryCode":67,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Zurich","NOT_YET_RECRUITING","Zurich","8091",{"type":69,"coordinates":82},[83,84],8.55,47.36667,{"lat":84,"lon":83},[87],{"name":88,"role":57,"phone":89,"phoneExt":16,"email":90},"Laura Horka, MD","+41 44 255 36 20","laura.horka@usz.ch",{"type":92,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[94,96,98,100],{"name":95,"class":6},"University of Zurich",{"name":97,"class":6},"University Hospital Freiburg",{"name":99,"class":6},"University Hospital Heidelberg",{"name":101,"class":6},"Medical University Innsbruck","100581615",false,"NCT06852612","Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I","Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I (GSD-DIET)","GSD-DIET","Inclusion Criteria:\n\n* Genetically and\u002For enzymatically confirmed diagnosis of GSDI (GSDIa or GSDIb)\n* Male or female ≥ 18y\n* Restriction of fructose intake in usual dietary treatment\n* Written informed consent\n\nExclusion Criteria:\n\n* Non-compliance with routine dietary treatment\n* Pregnancy or lactation\n* Liver transplant\n* Recurrent hospitalisations due to metabolic decompensation within the last 12 months\n* Severe chronic kidney disease with glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin\n* For GSDIb: Severe, uncontrolled symptomatic inflammatory bowel disease","ALL","18 Years",{"count":112,"type":113},20,"ESTIMATED","INTERVENTIONAL",[116],"NA","The present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose\u002Fgalactose in GSDI, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.",[119],"Glycogen Storage Disease Type I",[121,122,43,123],"Gsd1","Metabolism","Galactose","2026-05-07",{"date":126,"type":127},"2026-05-12","ACTUAL",{"date":129,"type":127},"2025-04-24",{"date":131,"type":113},"2027-03",{"name":5,"class":6},2]