[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532201":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":30,"locations":37,"responsibleParty":53,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vegetarian diet","EXPERIMENTAL","Vegetarian diet during five weeks",[13],"Other: Vegetarian diet",{"label":15,"type":16,"description":17,"interventionNames":18},"No change diet","NO_INTERVENTION","The 'habitual' diet during five weeks. There are no specific restrictions to their diet.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Participants will follow a vegetarian diet during a period of five weeks",[9],[24,27],{"name":25,"affiliation":5,"role":26},"Robin Nijveldt, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Saloua El Messaoudi, MD, PhD","STUDY_CHAIR",[31,35],{"name":25,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","0031243616785","robin.nijveldt@radboudumc.nl",{"name":28,"role":32,"phone":33,"phoneExt":18,"email":36},"Saloua.ElMessaoudi@radboudumc.nl",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Radboudumc","RECRUITING","Nijmegen","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],5.85278,51.8425,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":18,"phoneExt":18,"email":18},"Robin Nijveldt, MD",{"type":26,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Robin Nijveldt","Prof. dr.","100532201","vegetarian-diet-and-innate-immunity-in-patients-with-myocardial-infarction-and-in-healthy-volunteers-fresh-mi-study-100532201",false,"NCT06209723","Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)","Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)","FRESH-MI","Inclusion Criteria for patients:\n\n* Acute myocardial infarction (STEMI\u002FNSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \\\u003C1 week before randomisation\n* Body mass index between 18.5 and 35 kg\u002Fm2\n* Written informed consent\n\nInclusion Criteria for healthy volunteers (life partners \u002F souses)\n\n* Body mass index between 18.5 and 35 kg\u002Fm2\n* Written informed consent\n\nExclusion Criteria for patients and healthy volunteers:\n\n* Already on a vegetarian or vegan diet\n* Previous myocardial infarction\n* Diabetes Mellitus\n* Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)\n* Use of immunomodulatory drugs\n* Vaccination less than one month before start of intervention\n* Clinically significant infections within 1 months prior to start of intervention (defined as fever \\>38.5 degrees Celsius)\n* Active malignant haematological disease\n* Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)\n\nExclusion Criteria for healthy volunteers\n\n\\- Use of lipid lowering therapy",true,"ALL","18 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.",[75],"Myocardial Infarction","2026-08-12",{"date":78,"type":79},"2026-08-14","ACTUAL",{"date":81,"type":79},"2024-01-26",{"date":83,"type":69},"2027-09-01",{"name":5,"class":6},1]