[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585044":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":63,"collaborators":65,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":49,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Chalmers University of Technology","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Resistant starch","EXPERIMENTAL","Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period",[13,14,15],"Other: Resistant starch","Other: Slow digestible starch","Other: Rapid digestible starch",{"label":17,"type":18,"description":19,"interventionNames":20},"Slow digestible starch","ACTIVE_COMPARATOR","Participants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period",[13,14,15],{"label":22,"type":6,"description":23,"interventionNames":24},"Rapid digestible starch","Participants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period",[13,14,15],[26,29,31],{"type":6,"name":9,"description":11,"armGroupLabels":27,"otherNames":28},[22,9,17],null,{"type":6,"name":17,"description":19,"armGroupLabels":30,"otherNames":28},[22,9,17],{"type":6,"name":22,"description":23,"armGroupLabels":32,"otherNames":28},[22,9,17],[34],{"name":35,"affiliation":5,"role":36},"Rikard Landberg","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":28,"email":42},"Anna Hjort","CONTACT","0046317722848","anna.hjort@chalmers.se",{"name":35,"role":40,"phone":44,"phoneExt":28,"email":45},"0046317722732","rikard.landberg@chalmers.se",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Clinical Trial Center, Sahlgrenska University Hospital","RECRUITING","Gothenburg","Västra Götaland County","413 46","Sweden","SE",{"type":56,"coordinates":57},"Point",[58,59],11.96679,57.70716,{"lat":59,"lon":58},[62],{"name":39,"role":40,"phone":41,"phoneExt":28,"email":42},{"type":36,"investigatorFullName":35,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Professor",[66,69],{"name":67,"class":68},"Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy","UNKNOWN",{"name":70,"class":6},"Göteborg University","100585044","personalized-metabolic-responses-to-rapid-slow-and-resistant-starch-100585044",false,"NCT06897241","Personalized Metabolic Responses to Rapid, Slow and Resistant Starch","Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)","PerStarch","Inclusion Criteria:\n\n* Men and post-menopausal women\n* Age 30-75 years\n* BMI 27-40 kg\u002Fm2\n* Waist circumference \\> 102\u002F88 cm for men\u002Fwomen\n* Weight stable during previous 3 months (± 3 kg)\n* Willingness to consume the intervention diets\n* Ability to deal with the monitoring devices\n* Medications stable for the previous 14 days\n* Signed informed consent\n\nExclusion Criteria:\n\n* Cardiovascular events (myocardial infarction or stroke) during the previous 6 months\n* Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)\n* History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)\n* Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery\n* Renal or liver failure (creatinine \\\u003C1.7 mg\u002Fdl and alanine aminotransferase\u002Faspartate aminotransferase \\\u003C 2 times than normal values, respectively)\n* Anemia (hemoglobin below the age and sex specific normal reference ranges at screening)\n* Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion\n* Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.\n* Habitual use of probiotic\u002Fprebiotic supplements or foods enriched in probiotics\n* Celiac disease\n* Vegan\u002Fvegetarian diet (or a diet incompatible with protocol diets)\n* Intense physical activity regimen (\\> 7 h\u002Fweek of moderate intensity or \\> 3 h\u002Fweek of high intensity)\n* History of drug or alcohol abuse\n* Not able to understand written and spoken Swedish\n* Any other reason for lack of suitability for participation in the trial, as judged by the principal investor or co-principal investigator","ALL","30 Years","75 Years",{"count":83,"type":84},96,"ESTIMATED","INTERVENTIONAL",[87],"NA","The study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Each intervention will contain a different type of starch:\n\nA) Resistant starch B) Slow digestible starch C) Rapid digestible starch\n\nEach intervention will contain a preparation day, a meal challenge test day at clinic, a 14-day dietary intervention at home followed by a follow up visit at clinic. The interventions will be separated with a 14-day wash-out period, where participants are consuming their normal food.\n\nBlood, saliva and fecal samples will be collected during the trial, together with data from continuous glucose monitoring and body measurements. Questionnaires on dietary intake and lifestyle, food preferences, self-reported appetite, health-related quality of life, sleep quality and daytime sleepiness will also be filled out by the participants.",[90],"Adults With Overweight and Obesity",[92,93,94,95,96,97,98],"Glucose metabolism","Prevotella","AMY1 copy number","Continuous glucose monitoring","Meal tolerance test","Fecal redox potential","Home sampling","2025-05-14",{"date":101,"type":102},"2025-05-16","ACTUAL",{"date":104,"type":102},"2025-04-08",{"date":106,"type":84},"2026-05-01",{"name":5,"class":6},1]