[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593652":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":66,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":101,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"IRCCS Centro San Giovanni di Dio Fatebenefratelli","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Control group (CON)","ACTIVE_COMPARATOR",null,[13],"Behavioral: Mediterranean Diet",{"label":15,"type":16,"description":11,"interventionNames":17},"Group 2: CON + physical activity","EXPERIMENTAL",[13,18],"Behavioral: Physical Activity",{"label":20,"type":16,"description":11,"interventionNames":21},"Group 3: CON + Cognitive training",[13,22],"Behavioral: Cognitive Training",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"BEHAVIORAL","Mediterranean Diet","Participants will receive only the educational intervention about the Mediterranean diet. The program consists of 4-5 online sessions conducted by a nutritionist.",[9,15,20],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Physical Activity","In addition to educational sessions on the Mediterranean diet, there will be 2-3 weekly personalized exercise sessions, followed by a dedicated personal trainer at a partner gym. The treatment will last 12 weeks.",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Cognitive Training","In addition to educational sessions on the Mediterranean diet, there will be one weekly cognitive training session in groups, supervised by qualified staff at the IRCCS FBF. The treatment will last for 12 weeks.",[20],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Elisa Mombelli","CONTACT","(+39) 030 35 01 598","emombelli@fatebenefratelli.eu",{"name":44,"role":40,"phone":45,"phoneExt":11,"email":46},"Moira Marizzoni, PhD","(+39) 030 35 01 563","mmarizzoni@fatebenefratelli.eu",[48],{"facility":5,"status":49,"city":50,"state":11,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Brescia","25125","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],10.21472,45.53558,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":11,"phoneExt":11,"email":63},"Annamaria Cattaneo, PhD","acattaneo@fatebenefratelli.eu",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[67,69,71,73,75],{"name":68,"class":6},"Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)",{"name":70,"class":6},"University of Milan",{"name":72,"class":6},"China Medical University, China",{"name":74,"class":6},"University College Cork",{"name":76,"class":6},"Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement","100593652","lifestyle-interventions-to-prevent-cognitive-deficits-in-subjects-with-depressive-symptoms-from-mechanisms-to-clinical-practice-100593652",false,"NCT07009223","Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice","Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice","POWER","Inclusion Criteria:\n\n* Aged between 50 and 80 years;\n* Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Active gastrointestinal disorders;\n* Autoimmune disorders;\n* Chronic inflammatory disorders;\n* Diagnosis of dementia; cognitive impairment or mild functional impairment.\n* Use of antibiotics and\u002For anti-inflammatory drugs in the 8 weeks prior to the screening visit.","ALL","50 Years","80 Years",{"count":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline.\n\nThe main questions it aims to answer are:\n\n* Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?\n* Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?\n* Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?\n\nResearchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.\n\nThe participants:\n\n* Will take part to online sessions on healthy eating based on the Mediterranean diet\n* Some will do regular exercise, supervised by a personal trainer\n* Others will do weekly cognitive training in small groups at the hospital\n* They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.",[96,30,97,98,99,100],"Major Depressive Disorder (MDD)","Inflammation","Metabolome","Gut Microbiota","Depressive Symptoms",[102,103,104],"Depression","Cognition","nutrition","2026-02-09",{"date":107,"type":108},"2026-02-11","ACTUAL",{"date":110,"type":108},"2025-10-01",{"date":112,"type":90},"2028-03",{"name":5,"class":6},1]