[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545482":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":56,"collaborators":59,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":23,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"German Institute of Human Nutrition","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HP\u002FHC - HC\u002FHP","EXPERIMENTAL","Isocaloric 4-week HP\u002FHC intervention followed by a 4-week HC\u002FHP intervention.",[13],"Other: Diet with specific macronutrient composition.",{"label":15,"type":10,"description":16,"interventionNames":17},"HC\u002FHP - HP\u002FHC","Isocaloric 4-week HC\u002FHP intervention followed by a 4-week HP\u002FHC intervention.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Diet with specific macronutrient composition.","The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat.",[15,9],null,[25],{"name":26,"affiliation":5,"role":27},"Olga Ramich, PD Dr.","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},"CONTACT","+4933200882749","olga.ramich@dife.de",{"name":34,"role":30,"phone":35,"phoneExt":23,"email":36},"Marina D´Urso","+4933200882690","marina.durso@dife.de",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Olga Ramich","RECRUITING","Potsdam","Potsdam-Rehbrücke","14558","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],13.06566,52.39886,{"lat":50,"lon":49},[53,54],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},{"name":55,"role":30,"phone":35,"phoneExt":23,"email":36},"Marina D'Urso",{"type":27,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Olga Ramich (formerly Pivovarova)","Head of Research Group Molecular Nutritional Medicine",[60,62,65],{"name":61,"class":6},"Charite University, Berlin, Germany",{"name":63,"class":64},"Helmholtz Center Munich","UNKNOWN",{"name":66,"class":64},"Hasso Plattner Institute, Potsdam, Germany","100545482","protein-rich-meals-to-control-glucose-100545482",false,"NCT06382480","PROTeIn-rich Meals to Control Glucose","Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes","PROTIME","Inclusion Criteria:\n\n* Prediabetes (fasting blood sugar 100-125 mg\u002Fdl)\n* Diabetes type 2 (fasting blood sugar \\>126 mg\u002Fdl)\n* Overweight and obesity (BMI 25-50 kg\u002Fm2)\n\nExclusion Criteria:\n\n* Other diabetes types\n* Insulin treatment\n* Shift work\n* Weight changes \\>5% within past 3 months\n* Systemic glucocorticoid therapy\n* Systemic infections\n* Severe anemia\n* High blood pressure (\\>180\u002F110 mmHg)\n* Endocrinologic, liver and heart disorders\n* Immune diseases\n* Thyroid dysfunction\n* Heart attack or stroke\n* Cancer in the last 2 years\n* Eating disorders, food intolerance\u002Fallergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases\n* Hereditary or acquired coagulation disorders\n* Non-interruptible intake of blood thinners (anticoagulants)\n* Specific diets, intermittent fasting\n* Pregnancy or breastfeeding\n* Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study","ALL","18 Years","75 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.",[86,87,88,89],"Overweight","Obesity","Prediabetes","Type 2 Diabetes",[91,86,87,88,89,92,93,94,95,96,97,98],"Glucose","Metabolism","Chrononutrition","Macronutrient composition","High-protein","High-carb","Isocaloric diet","Prevention and treatment of type 2 diabetes","2025-08-19",{"date":101,"type":102},"2025-08-26","ACTUAL",{"date":104,"type":102},"2024-04-12",{"date":106,"type":80},"2027-02-28",{"name":5,"class":6},1]