[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569954":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":22,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":22,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":22,"overallStatus":77,"whyStopped":22,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Bonn","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"legume-rich Planetary Health Diet","EXPERIMENTAL","legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein",[13],"Other: legume-rich Planetary Health Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"control diet based on Western Diet low in legumes","diet based on the Western dietary pattern including animal protein sources (= control diet)",[18],"Other: control diet based on Western Diet low in legumes",[20,23],{"type":6,"name":9,"description":11,"armGroupLabels":21,"otherNames":22},[9],null,{"type":6,"name":15,"description":16,"armGroupLabels":24,"otherNames":22},[15],[26],{"name":27,"role":28,"phone":29,"phoneExt":22,"email":30},"Sarah Egert, Prof PhD","CONTACT","+ 49 (0) 228 \u002F 73 59 53","s.egert@uni-bonn.de",[32],{"facility":33,"status":22,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Institute of Nutritional and Food Sciences, Nutrition Physiology","Bonn","North Rhine-Westphalia","53113","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],7.09549,50.73438,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":47,"phoneExt":22,"email":30},"+ 49 (0) 228\u002F73 59 53",{"type":49,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Sarah Egert",[52,55],{"name":53,"class":54},"Federal Ministry of Food and Agriculture (BMEL)","UNKNOWN",{"name":56,"class":54},"Federal Office of Agriculture and Food (BLE)","100569954","effects-of-a-legume-rich-diet-in-the-context-of-the-planetary-health-diet-compared-to-a-western-oriented-dietary-pattern-in-participants-with-increased-cardiometabolic-risk-100569954",false,"NCT06700954","Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Participants with Increased Cardiometabolic Risk","Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases","LeguPlan_2","Inclusion Criteria:\n\n* written informed consent\n* Non-smoking\n* BMI: 27 - 34,9 kg\u002Fm2\n* Waist circumference (women ≥ 80 cm, men ≥ 94 cm)\n* Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg\n* At least one of the following criteria:\n* Fasting triglycerides in serum: ≥ 150 mg\u002FdL\n* Fasting LDL cholesterol in serum ≥160 mg\u002FdL\n* Fasting HDL-Cholesterol in serum: women \\\u003C 50 mg\u002Fdl, men \\\u003C 40 mg\u002FdL\n* Fasting glucose in plasma: ≥ 100 mg\u002FdL\n* CRP in serum 0,2-3 mg\u002FdL\n\nExclusion Criteria:\n\n* food intolerances and allergies (especially legumes)\n* Smoking\n* malabsorption syndromes\n* thyroid diseases\n* impaired renal function\n* chronic liver disease\n* heart failure\n* myocardial infarction\n* insulin-dependent diabetes mellitus\n* chronic inflammatory diseases\n* tumors\n* anemia\n* immunosuppression\n* intake of supplements (e.g., fish oil)\n* Participation in another study\n* other exclusion criteria at the discretion of the physician\u002F investigator","ALL","50 Years","75 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","The aim of the study is to systematically investigate the effects of a diet enriched with legumes in a dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires.",[76],"Cardiovascular Diseases","NOT_YET_RECRUITING","2024-11-19",{"date":80,"type":81},"2024-11-22","ACTUAL",{"date":83,"type":70},"2025-01-06",{"date":85,"type":70},"2025-12-31",{"name":5,"class":6},1]