[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646313":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":59,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":108,"whyStopped":25,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Buchinger Wilhelmi Development & Holding GmbH","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fibre Arm","ACTIVE_COMPARATOR","Participants (n=50) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive maize-derived resistant starch type IV at a total dose of 20 g per day. The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period. The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic. All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the control arm.",[13],"Dietary Supplement: Fibre Arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","PLACEBO_COMPARATOR","Participants (n=25) undergo a 10±4-day fasting period according to the Buchinger Wilhelmi fasting programme and receive corn starch placebo at a total dose of 1.2 g per day. The powder is blended into a carbohydrate-free electrolyte powder, divided into two equal daily doses, diluted in approximately 0.2 litres of water, and taken orally in the morning and at dinnertime throughout the fasting period. The fasting period is followed by a structured food reintroduction period according to the standard procedure of the Buchinger Wilhelmi Clinic. All other aspects of the intervention, including the fasting and nutritional protocol, clinical supervision, and study assessments, are identical to the intervention arm.",[19],"Dietary Supplement: Control Arm",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 20 g\u002Fday of maize-derived resistant starch type IV.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 1.2 g\u002Fday of corn starch placebo.",[15],[30],{"name":31,"affiliation":32,"role":33},"Andrea Siegler, Dr. med.","Buchinger Wilhelmi Development & Holding","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Elena Katharina Stroppel","CONTACT","00497551807675","katharina.stroppel@buchinger-wilhelmi.com",[41],{"facility":32,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Überlingen","Baden-Wurttemberg","88662","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],9.17136,47.76977,{"lat":51,"lon":50},[54,55],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":25,"role":37,"phone":25,"phoneExt":25,"email":56},"forschung@buchinger-wilhelmi.com",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[60,63,65,67,69,71],{"name":61,"class":62},"Buchinger Wilhelmi Clinic, 88662 Überlingen, Germany","UNKNOWN",{"name":64,"class":62},"King's College London, Faculty of Life Sciences & Medicine, Department of Nutritional Sciences, London, United Kingdom",{"name":66,"class":62},"Leiden University Medical Center, Department Leiden University Center for Infectious Diseases, 2333ZA, Leiden, Netherlands",{"name":68,"class":62},"TNO, Department Microbiology & Systems Biology, 2333 BE Leiden, Netherlands",{"name":70,"class":62},"Università degli Studi di Milano, Department of Pharmacological and Biomolecular Sciences Rodolfo Paoletti, Milan, Italy",{"name":72,"class":62},"Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy","100646313","combining-fasting-and-fibre-interventions-to-optimise-their-gut-microbiome-mediated-health-benefits-100646313",false,"NCT07691736","Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits","CoFFIe","Inclusion Criteria:\n\n* Men and women\n* Age: 18-65 years old\n* Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen\n* BMI ≥ 25 kg\u002Fm²\n* Signed informed consent\n\nExclusion Criteria:\n\n* intake of antibiotics up to 2 months prior the study\n* regular intake of pre-, post- and probiotics up to 2 months prior the study\n* diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease\n* medicated high blood pressure\n* diagnosed diabetes mellitus type I\n* medicated diabetes mellitus type II\n* diagnosed kidney stone\n* active malignant disease\n* known substance addiction\n* pregnancy or breastfeeding\n* diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency\n* inability to sign the informed consent\n* participation in another study",true,"ALL","18 Years","65 Years",{"count":85,"type":86},75,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis.\n\nThe randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.",[92,93,94,95,96],"Fasting","Dietary Fibre","Gut Microbiome","Metabolism Changes","Overweight , Obesity",[98,99,100,101,102,103,104,105,106,107],"long-term fasting","fasting","continuous glucose monitoring","fibre supplementation","gut microbiome","metabolic health","resistant starch IV","metabolomics","ketosis","extracellular vesicles","NOT_YET_RECRUITING","2026-07-02",{"date":111,"type":112},"2026-07-09","ACTUAL",{"date":114,"type":86},"2026-09-01",{"date":116,"type":86},"2027-03",{"name":5,"class":6},1]